pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
---|
diabetes type 2 | alogliptin | not classified | versus No demonstrated result for efficacy | 9 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Seino, 2011 | alogliptin vs | | | | Seino, 2011 | alogliptin vs | | | | Bosi , 2011 | alogliptin vs | | | | Kaku, 2011 | alogliptin vs | | | | Rosenstock, 2010 | alogliptin vs | | | | Rosenstock, 2009 | alogliptin vs | | | | Pratley, 2009 | alogliptin vs | | | | Pratley, 2009 | alogliptin vs | | | | DeFronzo , 2008 | alogliptin vs | | | |
Trial | Treatments | Patients | Method |
---|
Seino, 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Seino, 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Bosi , 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Kaku, 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Rosenstock, 2010 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Rosenstock, 2009 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Pratley, 2009 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Pratley, 2009 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | DeFronzo , 2008 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | alogliptin | not classified | versus placebo or control No demonstrated result for efficacy alogliptin inferior to placebo (add on MET) in terms of HbA1c goal <7% in Nauck, 2009 | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Nauck, 2009 | alogliptin vs placebo (add on MET) | | HbA1c goal <7% 2.40 [1.55; 3.70] | all hypoglycemia 0.00 [0.00; NaN] | EXAMINE, 2011 | alogliptin vs placebo | | | all cause deaths 0.88 [0.71; 1.08] CV deaths 0.80 [0.60; 1.05] stroke 0.90 [0.55; 1.48] MI 1.07 [0.88; 1.31] CV events 0.96 [0.83; 1.11] |
Trial | Treatments | Patients | Method |
---|
Nauck, 2009 | alogliptin 12.5 and 25 mg once daily (n=210) vs. placebo (n=104) | patients whose HbA(1c) levels were inadequately controlled on metformin alone | double-blind Parallel groups Sample size: 210/104 Primary endpoint: FU duration: 26 weeks | EXAMINE, 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | gliclazide | not classified | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Khanolkar, 2008 | gliclazide vs rosiglitazone (add on MET) | | | | Ristic, 2006 | gliclazide vs nateglinide (add on MET) | | | | Matthews, 2005 | gliclazide vs pioglitazone (add on MET) | | | |
Trial | Treatments | Patients | Method |
---|
Khanolkar, 2008 | metformin and gliclazide (n=-9) vs. metformin and rosiglitazone (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | Ristic, 2006 | gliclazide plus metformin (n=-9) vs. nateglinide plus metformin (n=-9) | | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 52 weeks | Matthews, 2005 | gliclazide 80 mg o.d. (titrated up to 320 mg (n=313) vs. pioglitazone 15 mg o.d. (titrated up to 45 mg (n=317) | Patients with poorly controlled type 2 diabetes | double-blind Sample size: 313/317 Primary endpoint: FU duration: 52 weeks |
|
diabetes type 2 | glimepiride | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Charpentier, 2001 | glimepiride monotherapy vs metformin | | | |
Trial | Treatments | Patients | Method |
---|
Charpentier, 2001 | glimepiride monotherapy (n=-9) vs. metformin monotherapy (n=-9) | Type 2 diabetic patients aged 35-70 years inadequately controlled by metformin monotherapy 2550 mg daily for at least 4 weeks | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 20 weeks |
|
diabetes type 2 | glimeripide | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
LEAD-2 (Nauck) Sulf vs pbo, 2009 | glimepiride vs placebo (add on MET) | | | |
Trial | Treatments | Patients | Method |
---|
LEAD-2 (Nauck) Sulf vs pbo, 2009 | glimepiride (4 mg once daily). (n=-9) vs. placebo (n=-9) | subjects previously treated with oral antidiabetes (OAD) therapy | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 26 weeks |
|
diabetes type 2 | glimeripide | not classified | versus placebo No demonstrated result for efficacy | 8 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | Charpentier, 2001 | glimepiride vs placebo (add on MET) | | | CV death 1.00 [0.38; 2.62] All-cause mortality 1.00 [0.38; 2.62] Stroke 1.00 [0.38; 2.62] Myocardial infarction 1.00 [0.38; 2.62] | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Study 201 (Goldberg), 1996 | glimepiride, 1, 4, or 8 mg once daily (n=304) vs. placebo (n=0) | patients with NIDDM | double-blind Parallel groups Sample size: 304/0 Primary endpoint: FU duration: 14 weeks | Schade, 1998 | glimepiride at individually determined optimal dose (1-8 mg of glimepiride) for 10+12 weeks (n=123) vs. placebo (n=126) | patients with type 2 diabetes mellitus for whom diet therapy is unsuccessful | double-blind Parallel groups Sample size: 123/126 Primary endpoint: FU duration: | Rosenstock, 1996 | glimepiride 8 mg q.d., 4 mg b.i.d., 16 mg q.d., or 8 mg b.i.d (n=416) vs. placebo (n=0) | previously treated NIDDM patients | double-blind Parallel groups Sample size: 416/0 Primary endpoint: FU duration: 14 weeks | Luis Bautista, 2003 | glimepiride with titration to 2 mg and 4 mg for FPG levels >120 mg/dL (n=-9) vs. placebo (n=-9) | Mexican American Patients with type 2 diabetes mellitus | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: change in HbA(1c) FU duration: 14 weeks | Charpentier, 2001 | metformin and glimepiride (n=-9) vs. metformin (n=-9) metformin, glimepiride or metformin and glimepiride | Type 2 diabetic patients aged 35-70 years inadequately controlled by metformin monotherapy 2550 mg daily | double-blind Sample size: -9/-9 Primary endpoint: FU duration: | Kaneko, 1993 | glimepiride 0.25mg od, 0.5mg od (n=62) vs. placebo (n=31) | | Sample size: 62/31 Primary endpoint: FU duration: | Study 202 | glimepiride 1-8mg od (n=122) vs. placebo (n=125) | | Sample size: 122/125 Primary endpoint: FU duration: | Riddle, 1994 | Glimepiride (16 mg/day) plus insulin (n=72) vs. insulin
plus placebo (n=73) | obese
patients with type 2 diabetes insufficiently controlled
by full dosages of sulphonylureas (glimepiride titrated up to 8mg twice daily and with laboratory-monitored FPG of 10 to 16
mmol/L (180 to 300 mg/dl)) | Sample size: 72/73 Primary endpoint: FU duration: |
|
diabetes type 2 | glimeripide | not classified | versus gliclazide No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Charpentier (301F) | glimepiride 1-4mg od (n=96) vs. gliclazide 80-320 mg/day (od or bid) (n=107) | | Sample size: 96/107 Primary endpoint: FU duration: |
|
diabetes type 2 | glimeripide | not classified | versus Sulfonylurea No demonstrated result for efficacy | 6 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Draeger, 1996 | glimepiride 1 mg daily (n=524) vs. 2.5 mg glibenclamide (n=520) | type 2 diabetic patients stabilised on glibenclamide | double-blind Parallel groups Sample size: 524/520 Primary endpoint: not unique FU duration: | Dills, 1996 | glimepiride 1-16mg od (n=289) vs. non-micronized glyburide 1.25-20mg od (n=288) | patients with non-insulin dependent diabetes | double-blind Parallel groups Sample size: 289/288 Primary endpoint: FU duration: | Inukai, 2005 | glimepiride (n=172) vs. gliclazide or glibenclamide (n=0) | Japanese type 2 diabetic patients (HbA1C > or = 7.0%), maintained on a conventional SU | open Parallel groups Sample size: 172/0 Primary endpoint: FU duration: 6 months | Protocol 311 | glimepiride 1-8mg od (n=427) vs. glibenclamide 1.75-14 mg/day
(od or bid) (n=425) | | Sample size: 427/425 Primary endpoint: FU duration: | Clark (301), 1997 | glimepiride 1-16 mg/day (od or bid) (n=444) vs. glipizide 2.5-40 mg/day (od or bid) (n=208) | | Sample size: 444/208 Primary endpoint: FU duration: | Sonnenberg, 1997 | glimepirid e6mg od (n=50) vs. glimepiride 3mg bid (n=48) | | Cross over Sample size: 50/48 Primary endpoint: FU duration: |
|
diabetes type 2 | glipizide | not classified | versus No demonstrated result for efficacy | 8 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Nauck, 2007 | glipizide vs sitagliptin (add on MET) | | | | Feinglos, 2005 | glipizide GITS vs placebo (add on MET) | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Nauck, 2007 | glipizide (n=-9) vs. sitagliptin (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: 52 weeks | Feinglos, 2005 | 2.5 mg glipizide GITS (n=61) vs. placebo (n=61) | type 2 diabetes inadequately controlled (A1c 7-8.5%) on metformin (> or =1000 mg/day for > or =3 months) | double-blind Sample size: 61/61 Primary endpoint: FU duration: 16 weeks | Rosenstock, 1993 | glipizide, 2.5 or 5 mg/day (n=139) vs. glyburide, 1.25 or 2.5 mg/day (n=0) | elderly patients with NIDDM that was controlled for at least 3 months with oral sulfonylurea therapy | open Parallel groups Sample size: 139/0 Primary endpoint: FU duration: 4 months | Birkeland, 1994 | glipizide (n=-9) vs. glyburide (n=-9) | NIDDM patients | Sample size: -9/-9 Primary endpoint: FU duration: | Birkeland, 1994 | glipizide (n=-9) vs. glyburide (n=-9) | NIDDM patients | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 15 months | Simonson, 1997 | once-daily doses of 5, 20, 40, or 60 mg glipizide GITS (n=-9) vs. placebo (n=-9) | NIDDM patients | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 4+8 weeks | Testa, 1998 | 5 to 20 mg of glipizide gastrointestinal therapeutic system (GITS) (n=377) vs. placebo (n=192) | patients with type 2 diabetes mellitus | Parallel groups Sample size: 377/192 Primary endpoint: FU duration: 12 weeks | Goldstein | glipizide/metformin 5/500 mg tablets (n=-9) vs. metformin 500-mg (n=-9) glipizide 30-mg, metformin 500-mg, or glipizide/metformin 5/500 mg | patients with type 2 DM that is uncontrolled by at least half the maximum labeled daily dose of a sulfonylurea | open Cross over Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | glyburide | not classified | versus No demonstrated result for efficacy | 10 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Garber, 2006 | glibenclamide vs rosiglitazone (add on MET) | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Garber, 2006 | metformin-glibenclamide 500/2.5 mg tablets (initial daily dose 1000/5 mg) (n=-9) vs. metformin 500 mg plus rosiglitazone 4 mg (initial daily dose 1000-2000 mg + 4 mg, depending on previous treatment) (n=-9) | patients with type 2 diabetes inadequately controlled on metformin monotherapy | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | Garber, 2002 | glyburide 2.5 mg (n=-9) vs. placebo (n=-9) | patients with type 2 diabetes who had failed diet and exercise | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: | Vray, 1995 | glibenclamide (2.5 mg X 3/d) (n=-9) vs. placebo (n=-9) | type 2 diabetic outpatients, 40-70 years of age, treated by diet alone or oral anti-diabetic drugs | double-blind Factorial plan Sample size: -9/-9 Primary endpoint: FU duration: | Hermann, 1991 | metformin + glibenclamide (n=-9) vs. metformin (n=-9) metformin, glibenclamide or the combination of both | patients with non-insulin-dependent diabetes mellitus | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 6 months | DeFronzo, 1995 | metformin and glyburide (n=-9) vs. metformin (n=-9) metformin and glyburide vs. metformin vs. glyburide | patients with non-insulin-dependent diabetes mellitus | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 29 weeks | Erle, 1999 | low-dose glyburide plus metformin (n=-9) vs. high-dose glyburide alone (n=-9) | | Cross over Sample size: -9/-9 Primary endpoint: FU duration: | Marre (ass), 2002 | metformin-glibenclamide 500 mg/2.5 mg or metformin-glibenclamide 500 mg/5 mg, titrated with the intention to achieve fasting plasma glucose (FPG) < or = 7 mmol/l (n=-9) vs. metformin 500 mg, (n=-9) metformin 500 mg, glibenclamide 5 mg, metformin-glibenclamide 500 mg/2.5 mg or metformin-glibenclamide 500 mg/5 mg | patients with Type 2 diabetes mellitus inadequately controlled by metformin monotherapy | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 16 weeks | Blonde, 2002 | glyburide/metformin 2.5 mg/500 mg (n = 160); or glyburide/metformin 5 mg/500 mg (n = 162) (n=-9) vs. metformin 500 mg (n=-9) glyburide 10 mg b.i.d. (n = 164); metformin 500 mg (n = 153); glyburide/metformin 2.5 mg/500 mg (n = 160); or glyburide/metformin 5 mg/500 mg | patients with inadequate glycaemic control on at least half-maximal dose of sulphonylurea | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 16 weeks | Tosi, 2003 | metformin 400 to 2,400 mg/d + glibenclamide 2.5 to 15 mg/d (n=-9) vs. metformin (500 to 3,000 mg/d), (n=-9) metformin (500 to 3,000 mg/d), glibenclamide (5 to 15 mg/d), or their combination (metformin 400 to 2,400 mg/d + glibenclamide 2.5 to 15 mg/d | | double-blind Cross over Sample size: -9/-9 Primary endpoint: FU duration: 6 months | Garber, 2003 | glyburide/metformin (n=-9) vs. metformin (n=-9) glyburide/metformin tablets vs. metformin or glyburide monotherapy | patients with type 2 diabetes who had inadequate glycemic control [glycosylated hemoglobin A(1C) (A1C), >7% and <12%) with diet and exercise alone | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | linagliptin | not classified | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Owens | linagliptin vs Metformin + sulfonylurea | | | | Forst, 2010 | linagliptin vs | | | |
Trial | Treatments | Patients | Method |
---|
Owens | linagliptin
(n=-9) vs. combination of metformin and an SU
(n=-9)
| type 2 diabetes mellitus with insufficient glycaemic control with metformin in combination with a sulphonylurea
| Sample size: -9/-9 Primary endpoint: change from baseline in HbA1c FU duration: 24 weeks
| Forst, 2010 | Linagliptin (1, 5, or 10 mg taken once daily)
(n=-9) vs. placebo (on top Metformin )
(n=-9)
| patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels
| double-blind Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks
|
|
diabetes type 2 | linagliptin | not classified | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Taskinen | linagliptin vs placebo (add on MET) | | | | Lewin, 2010 | linagliptin vs placebo (add on SU) | | | | Del Prato | linagliptin vs placebo | | | | Gomis, 2011 | linagliptin vs placebo (add on pioglitazone) | | | |
Trial | Treatments | Patients | Method |
---|
Taskinen | linagliptin 5 mg once daily (n=524) vs. placebo add on MET (n=177) | patients with inadequately controlled type 2 diabetes for whom metformin therapy is inappropriate due to intolerability or contraindication | Sample size: 524/177 Primary endpoint: FU duration: | Lewin, 2010 | linagliptin 5 mg
(n=-9) vs. placebo (add-on to sulphonylurea)
(n=-9)
| patients with type 2 diabetes and insufficient glycaemic control
| double-blind Sample size: -9/-9 Primary endpoint: change from baseline HbA1c FU duration: 18 weeks
| Del Prato | Linagliptin monotherapy
(n=-9) vs. placebo
(n=-9)
| Type 2 Diabetic Patients With Insufficient Glycemic Control
| double-blind Sample size: -9/-9 Primary endpoint: change from baseline in HbA1c FU duration: 24 weeks
| Gomis, 2011 | initial combination of 30 mg pioglitazone plus 5 mg linagliptin (n=-9) vs. pioglitazone plus placebo (n=-9) | patients with inadequately controlled type 2 diabetes | Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks |
|
diabetes type 2 | linagliptin | not classified | versus SU No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CAROLINA, 2012 | linagliptin vs glimepiride | CV events 0.46 [0.23; 0.91] | | CVdeath 1.00 [0.14; 7.14] | Gallwitz, 2012 | linagliptin vs glimepiride (add on MET) | | | |
Trial | Treatments | Patients | Method |
---|
CAROLINA, 2012 | linagliptin (n=776) vs. glimepiride 1-4 mg QD (n=775) | patients with type 2 diabetes at elevated cardiovascular risk receiving usual care | double-blind Sample size: 776/775 Primary endpoint: change in HbA1c FU duration: 2 years | Gallwitz, 2012 | linagliptin (5 mg once daily) add-on therapy to preferably > 1500 mg metformin (n=777) vs. glimepiride (1—4 mg) orally once daily add-on therapy to preferably > 1500 mg metformin (n=775) | type 2 diabetes mellitus with insufficient glycaemic control with metformin | double-blind Parallel groups Sample size: 777/775 Primary endpoint: change from baseline in HbA1c FU duration: 104 weeks |
|
diabetes type 2 | mitiglinide | not classified | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Gao | mitiglinide 10 - 20 mg three times daily (n=291) vs. nateglinide 120 mg three times daily (n=0) | Chinese type 2 diabetes mellitus patients | double-blind Parallel groups Sample size: 291/0 Primary endpoint: FU duration: 20 weeks | Kaku, 2009 | additional mitiglinide 5 or 10 mg tid (n=-9) vs. placebo on top pioglitazone (n=-9) | Japanese type 2 diabetic patients who are insufficiently controlled by pioglitazone monotherapy | multicenter Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 16 weeks | Kumashiro, 2007 | mitiglinide (n=-9) vs. on top of once daily insulin glargine (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | nateglinide | not classified | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Li, 2009 | Nateglinide (n=-9) vs. repaglinide (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Li, 2007 | nateglinide 90 mg three times daily (n=115) vs. repaglinide 1.0 mg three times daily (n=115) | Chinese patients with type 2 diabetes | Parallel groups Sample size: 115/115 Primary endpoint: FU duration: 12 weeks |
|
diabetes type 2 | nateglinide | not classified | versus placebo or control No demonstrated result for efficacy | 9 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Marre, 2002 | nateglinide 60 mg, 120 mg before three meals (n=-9) vs. placebo (n=-9) | metformin-treated patients with HbA1c between 6.8% and 11% | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: | Horton, 2000 | 120 mg nateglinide before meals (n=179) vs. placebo (n=172) | patients with an HbA1c level between 6.8 and 11.0% during a 4-week placebo run-in | double-blind Parallel groups Sample size: 179/172 Primary endpoint: FU duration: | Hanefeld, 1990 | nateglinide at doses of 30 mg, 60 mg, 120 mg, or 180 mg (n=229) vs. placebo (n=60) | | double-blind Parallel groups Sample size: 229/60 Primary endpoint: FU duration: 12 weeks | Saloranta, 2002 | nateglinide (30, 60, or 120 mg, with meals). (n=675) vs. placebo (n=0) | patients with type 2 diabetes but only moderately elevated fasting plasma glucose (FPG = 7.0-8.3 mmol/liter) | double-blind Parallel groups Sample size: 675/0 Primary endpoint: FU duration: 24 weeks | Mari, 2005 | 30, 60, or 120 mg nateglinide (n=108) vs. placebo (n=0) | mild type 2 diabetic men and women (fasting glucose 7.0-8.3 mmol/l) on diet treatment | double_blind Parallel groups Sample size: 108/0 Primary endpoint: FU duration: 24 weeks | Goldberg, 1998 | repaglinide (n=66) vs. placebo (n=33) | type 2 diabetes | double-blind Parallel groups Sample size: 66/33 Primary endpoint: FU duration: | Jovanovic, 2000 | repaglinide 1 mg or repaglinide 4 mg (n=286) vs. placebo (n=75) | | double-blind Parallel groups Sample size: 286/75 Primary endpoint: FU duration: 24 weeks | Bech, 2003 | repaglinide initiated at 0.5 mg per meal, increased to 1 mg after 4 weeks if fasting plasma glucose exceeded 7.8 mmol/l. (n=253) vs. placebo (n=0) | pharmacotherapy-naive patients with Type 2 diabetes | double-blind Parallel groups Sample size: 253/0 Primary endpoint: FU duration: 16 weeks | Moses, 2001 | 0.5 mg repaglinide at mealtimes (increased to 1 mg after 4 weeks depending on blood glucose response) (n=408) vs. placebo (n=0) | patients with type 2 diabetes considered poorly controlled by diet, but without a history of previous antidiabetic medication | double-blind Parallel groups Sample size: 408/0 Primary endpoint: FU duration: 16 weeks |
|
diabetes type 2 | nateglinide | not classified | versus active treatment No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Ristic, 2006 | nateglinide plus metformin (n=133) vs. gliclazide plus metformin (n=129) | Patients with inadequate glucose control on maximal doses of metformin | double-blind Parallel groups Sample size: 133/129 Primary endpoint: FU duration: 24 weeks |
|
diabetes type 2 | repaglinide | not classified | versus No demonstrated result for efficacy | 9 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Lund, 2007 | repaglinide 2 mg thrice daily (n=-9) vs. metformin 1 g twice daily (n=-9) | non-obese patients with type 2 diabetes | double-blind Cross over Sample size: -9/-9 Primary endpoint: FU duration: | Landgraf, 1999 | repaglinide, administered preprandially three times daily (n=-9) vs. glibenclamide, given preprandially once or twice daily (n=-9) | | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 14 weeks | Marbury, 1999 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Wolffenbuttel, 1999 | repaglinide (0.5-4 mg t.i.d.) (n=211) vs. glyburide (1.75-10.5 mg daily) (n=109) | | double-blind Sample size: 211/109 Primary endpoint: FU duration: 1 year | Madsbad, 2001 | repaglinide, 1-4 mg at mealtimes (n=256) vs. glipizide, 5-15 mg daily (n=0) | | double-blind Sample size: 256/0 Primary endpoint: FU duration: 1 year | Raskin, 2000 | repaglinide (0.5–4.0 mg at meals), (n=256) vs. combination of repaglinide (1–4 mg at meals) and troglitazone (200–600 mg once
daily) (n=0) | Patients with type 2 diabetes who
had inadequate glycemic control (HbA1c 7.0%) during previous monotherapy | open Sample size: 256/0 Primary endpoint: FU duration: 22 weeks | Raskin, 2001 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Raskin, 2001 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Landin-Olsson, 1999 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | repaglinide | not classified | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
Moses, 1999 | prestudy dose of metformin with the addition of repaglinide (n=27) vs. prestudy dose of metformin (n=27) | patients with type 2 diabetes who had inadequate glycemic control (HbA1c > 7.1%) when receiving the antidiabetic agent metformin | open Parallel groups Sample size: 27/27 Primary endpoint: FU duration: 12 weeks | Chuang, 1999 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Goldberg, 1998 | repaglinide (n=66) vs. placebo (n=33) | patients with type 2 diabetes | double-blind Parallel groups Sample size: 66/33 Primary endpoint: FU duration: 18 weeks | Jovanovic, 2000 | repaglinide 1 mg (n = 140), or repaglinide 4 mg (n = 146) (n=286) vs. placebo (n=75) | | double-blind Sample size: 286/75 Primary endpoint: FU duration: 24 weeks |
|
diabetes type 2 | saxagliptin | not classified | versus No demonstrated result for efficacy | 10 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CV181-040 | saxagliptin + glyburide vs glyburide uptitration | | | | Kawamori, 2012 | saxagliptin vs | | | | Forst, 2011 | Saxagliptin vs | | | | Fonseca, 2012 | saxagliptin vs | | | | Nowicki, 2011 | saxagliptin vs | | | | Yang, 2011 | saxagliptin vs | | | | Nowicki, 2011 | saxagliptin vs | | | | Göke, 2010 | saxagliptin vs | | | | Scheen , 2010 | saxagliptin vs | | | | Stenlöf , 2010 | Saxagliptin vs | | | |
Trial | Treatments | Patients | Method |
---|
CV181-040 | saxagliptin added to a submaximal sulphonylurea dose (n=-9) vs. uptitration of sulphonylurea monotherapy (n=-9) | patients with type 2 diabetes and inadequate glycaemic control with sulphonylurea monotherapy | Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | Kawamori, 2012 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Forst, 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Fonseca, 2012 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Nowicki, 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Yang, 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Nowicki, 2011 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Göke, 2010 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Scheen , 2010 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Stenlöf , 2010 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | saxagliptin | not classified | versus biguanides No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CV181-085 | saxagliptin plus metformin XR 1500mg vs metformin up to 2000mg | | | |
Trial | Treatments | Patients | Method |
---|
CV181-085 | Saxagliptin in Combination With Metformin XR 1500 mg (n=-9) vs. Up-titrated Metformin XR to 2000 mg (n=-9) | Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg | Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | saxagliptin | not classified | versus placebo or control No demonstrated result for efficacy saxagliptin inferior to placebo (add on MET) in terms of HbA1c goal <7% in DeFronzo, 2009 saxagliptin inferior to placebo in terms of HbA1c goal <7% in SAVOR-TIMI 53, 2013 | 12 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
DeFronzo, 2009 | saxagliptin vs placebo (add on MET) | | HbA1c goal <7% 2.63 [1.81; 3.81] | all hypoglycemia 0.94 [0.06; 14.87] | saxgliptin, renal study | saxagliptin vs placebo (add on current treatment) | | | | Rosenstock, 2008 | saxagliptin vs placebo (monotherapy) | | | | CV181-011 | saxagliptin vs placebo (monotherapy) | | | | CV181-038 | saxagliptin vs placebo (monotherapy) | | | | Jadzinsky, 2009 | saxagliptin vs placebo (add on MET) | | | | CV181-057 | saxagliptin vs placebo (add on insulin) | | | | CV181-066 | saxagliptin vs placebo (add on MET) | | | | CV181-080 | saxagliptin vs placebo (add on MET) | | | | Hollander | saxagliptin vs placebo (add on TZD) | | | | CV181-041 | saxagliptin vs placebo (monotherapy) | | | | SAVOR-TIMI 53, 2013 | saxagliptin vs placebo | | HbA1c goal <7% 1.32 [1.25; 1.39] | all hypoglycemia 1.22 [0.82; 1.83] nephropathy 1.08 [0.88; 1.32] all cause deaths 1.10 [0.96; 1.26] CV deaths 1.03 [0.87; 1.21] stroke 1.10 [0.88; 1.38] MI 0.95 [0.80; 1.12] CV events 1.00 [0.90; 1.11] |
Trial | Treatments | Patients | Method |
---|
DeFronzo, 2009 | saxagliptin (2.5, 5, or 10 mg once daily) (n=191) vs. placebo (n=179) | Patients With Inadequately Controlled
Type 2 Diabetes With Metformin Alone | Sample size: 191/179 Primary endpoint: FU duration: 24 weeks | saxgliptin, renal study | saxagliptin (n=-9) vs. placebo added to patients’ current diabetes treatment (n=-9) | patients with moderate to severe renal impairment or end-stage renal disease | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks | Rosenstock, 2008 | saxagliptin 2.5, 5, 10, 20 or 40 mg once daily (n=-9) vs. placebo (n=-9) | drug-naive patients with T2DM and inadequate glycaemic control | Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks | CV181-011 | oral saxagliptin 2.5, 5, or 10 mg once daily (n=-9) vs. placebo (n=-9) treatment-naïve patients with type 2 diabetes | | Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | CV181-038 | Saxagliptin monotherapy (n=-9) vs. placebo (n=-9) | type 2 diabetic subjects who are not controlled with diet and exercise | Sample size: -9/-9 Primary endpoint: FU duration: | Jadzinsky, 2009 | saxagliptin (n=-9) vs. placebo (n=-9) | treatment-naïve patients with type 2 diabetes (T2D) and inadequate glycaemic control | Sample size: -9/-9 Primary endpoint: FU duration: | CV181-057 | Saxagliptin, 5 mg (n=-9) vs. placebo (on top insulin) (n=-9) | Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin | Sample size: -9/-9 Primary endpoint: FU duration: | CV181-066 | Saxagliptin (n=-9) vs. placebo (n=-9) | Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ¡Ý1500 mg/Day | Sample size: -9/-9 Primary endpoint: FU duration: | CV181-080 | 2.5 mg Saxagliptin, Twice Daily (n=-9) vs. placebo (n=-9) | Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone | Sample size: -9/-9 Primary endpoint: FU duration: | Hollander | saxagliptin (2.5 or 5 mg) (n=-9) vs. placebo (n=-9) | patients with type 2 diabetes and inadequate control on thiazolidinedione alone | Sample size: -9/-9 Primary endpoint: FU duration: | CV181-041 | Saxagliptin (n=-9) vs. placebo (n=-9) | Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise | Sample size: -9/-9 Primary endpoint: FU duration: | SAVOR-TIMI 53, 2013 | Saxagliptin 5 mg or 2.5 mg once daily
(n=16500) vs. Placebo (n=0) | Patients With Type 2 Diabetes | Parallel groups Sample size: 16500/0 Primary endpoint: cardiovascular death, MI, ischaemic stroke, FU duration: |
|
diabetes type 2 | saxagliptin | not classified | versus SU No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
saxagliptin | saxagliptin vs glipizide | | | | saxagliptin vs sitagliptin | saxagliptin vs sitagliptin (add on MET) | | | |
Trial | Treatments | Patients | Method |
---|
saxagliptin | saxagliptin (n=-9) vs. titrated glipizide plus metformin (n=-9) | adult patients with type 2 diabetes and inadequate glycemic control | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 52 weeks | saxagliptin vs sitagliptin | saxagliptin 5 mg once daily add on metformin (n=403) vs. sitagliptin 100 mg onece daily add on metformin (n=398) | adults with type 2 diabetes who did not attain adequate glycemic control on metformin therapy alone | Parallel groups Sample size: 403/398 Primary endpoint: FU duration: 18 weeks |
|
diabetes type 2 | sitagliptin | not classified | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Stafford , 2011 | sitagliptin vs | | | | Reasner, 2011 | sitagliptin vs control (add on MET) | | | | Rigby , 2010 | sitagliptin vs rosiglitazone (add on MET) | | | |
Trial | Treatments | Patients | Method |
---|
Stafford , 2011 | (n=-9) vs. (n=-9) | older adults with type 2 diabetes mellitus | Sample size: -9/-9 Primary endpoint: FU duration: | Reasner, 2011 | sitagliptin/metformin 50/500 mg bid uptitrated over 4 weeks to achieve maximum doses of sitagliptin/metformin 50/1000 mg bid (n=-9) vs. metformin monotherapy (n=-9) | drug-naive patients with type 2 diabetes | NA Cross over Sample size: -9/-9 Primary endpoint: FU duration: | Rigby , 2010 | sitagliptin phosphate, 100 mg daily (n=-9) vs. rosiglitazone maleate, 4 mg daily (n=-9) | type 2 diabetes mellitus inadequately controlled by metformin monotherapy | open Sample size: -9/-9 Primary endpoint: FU duration: 16 weeks |
|
diabetes type 2 | sitagliptin | not classified | versus alpha-glucosidase inhibitor No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Iwamoto , 2010 | sitagliptin monotherapy vs voglibose | | | |
Trial | Treatments | Patients | Method |
---|
Iwamoto , 2010 | sitagliptin 50 mg once daily monotherapy (n=-9) vs. voglibose 0.2 mg thrice daily before meals (n=-9) | Japanese patients with type 2 diabetes | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks |
|
diabetes type 2 | sitagliptin | not classified | versus placebo or control No demonstrated result for efficacy | 17 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Aschner, 2006 | sitagliptin monotherapy vs placebo | | | Adverse events leading to treatment discontinuation 0.96 [0.40; 2.31] | Goldstein, 2007 | sitagliptin vs placebo | | | Adverse events leading to treatment discontinuation 0.74 [0.32; 1.71] | Hanefeld, 2007 | sitagliptin vs placebo | | | Adverse events leading to treatment discontinuation 1.01 [0.39; 2.59] | Nonaka, 2008 | sitagliptin monotherapy vs placebo | | | Adverse events leading to treatment discontinuation 0.00 [0.00; NaN] | Raz, 2006 | sitagliptin monotherapy vs placebo | | | Adverse events leading to treatment discontinuation 0.00 [0.00; NaN] | Scott* (sit vs pbo), 2007 | sitagliptin 50mg bid monotherapy vs placebo | | | Adverse events leading to treatment discontinuation 3.07 [0.32; 29.15] | Charbonnel, 2006 | sitagliptin vs placebo (add on MET) | | | Adverse events leading to treatment discontinuation 1.34 [0.60; 2.98] | Hermansen, 2007 | sitagliptin vs placebo (on-top glimepiride+/- metformine) | | | Adverse events leading to treatment discontinuation 2.74 [0.29; 25.95] | Nauck, 2007 | sitagliptin vs placebo (add on MET) | | | Adverse events leading to treatment discontinuation 0.76 [0.40; 1.44] | Rosenstock (sit on top pio vs pbo), 2006 | sitagliptin vs placebo (on top PIO) | Adverse events leading to treatment discontinuation 5.59 [1.26; 24.88] | | | Scott** (sit vs pbo on top met), 2007 | sitagliptin vs placebo (add on MET) | | | Adverse events leading to treatment discontinuation 3.87 [0.44; 33.99] | Barzilai, 2011 | sitagliptin monotherapy vs placebo | | | | Vilsbøll, 2010 | sitagliptin vs placebo (add on insulin+/-MET) | | | | Mohan , 2009 | sitagliptin monotherapy vs placebo | | | | Chan, 2008 | sitagliptin monotherapy vs placebo | | | | raz, 2008 | sitagliptin vs placebo (add on MET) | | | | Rosenstock , 2006 | sitagliptin vs placebo (add on PIO) | | | |
Trial | Treatments | Patients | Method |
---|
Aschner, 2006 | sitagliptin 100 or 200 mg dailym (n=-9) vs. placebo (n=-9) | patients with type 2 diabetes | Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | Goldstein, 2007 | sitagliptin 100 mg daily (n=-9) vs. placebo (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Hanefeld, 2007 | sitagliptin 25 mg or 50 mg or 100 mg dailyi (n=-9) vs. placebo (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Nonaka, 2008 | sitagliptin 100 mg daily monotherapy (n=-9) vs. placebo (n=-9) | Japanese patients with type 2 diabetes | double-blind Sample size: -9/-9 Primary endpoint: FU duration: | Raz, 2006 | sitagliptin 100 mg (or 200 mg) daily (n=-9) vs. placebo (n=-9) | patients with type 2 diabetes mellitus and inadequate glycaemic control | Sample size: -9/-9 Primary endpoint: FU duration: | Scott* (sit vs pbo), 2007 | sitagliptin 50 mg b.i.d (n=-9) vs. placebo (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Charbonnel, 2006 | sitagliptin 100 mg daily (add-on to metformin therapy)j (n=-9) vs. placebo (add-on tometformin therapy); (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Hermansen, 2007 | sitagliptin 100 mg daily (add-on to ongoing stable doses of glimepiride, alone or in combination with metformin)ocumen (n=-9) vs. placebo (add-on to ongoing stable doses of glimepiride, alone or in combination with metformin); (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Nauck, 2007 | sitagliptin 100 mg daily (add-on to metformin therapy)j (n=-9) vs. placebo (add-on to metformin therapy); (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Rosenstock (sit on top pio vs pbo), 2006 | sitagliptin 100 mg daily (add-on to pioglitazone therapy)sl˜ðõØ (n=-9) vs. placebo (add-on to pioglitazone therapy); (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Scott** (sit vs pbo on top met), 2007 | sitagliptin 100 mg daily (add-on to metformin therapy)j (n=-9) vs. placebo (add-on to metformin therapy). (n=-9) | patients with type 2 diabetes who were inadequately on mET monotherapy | Sample size: -9/-9 Primary endpoint: FU duration: | Barzilai, 2011 | once-daily sitagliptin (100 or 50 mg, depending on renal function) (n=-9) vs. placebo (n=-9) | elderly patients with type 2 diabetes | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | Vilsbøll, 2010 | once-daily sitagliptin 100 mg (n=322) vs. placebo (n=319) | patients with type 2 diabetes inadequately controlled on long-acting, intermediate-acting or premixed insulin | double-blind Sample size: 322/319 Primary endpoint: FU duration: | Mohan , 2009 | sitagliptin 100mg once daily monotherapy (n=-9) vs. placebo (n=-9) | Chinese, Indian, and Korean patients with type 2 diabetes inadequately controlled by diet and exercise. | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 18 weeks | Chan, 2008 | sitagliptin (n=65) vs. placebo (n=26) | patients with type 2 diabetes and chronic renal insufficiency | double-blind Sample size: 65/26 Primary endpoint: FU duration: 12 weeks | raz, 2008 | sitagliptin 100 mg once daily (n=-9) vs. placebo (n=-9) | patients with type 2 diabetes | Sample size: -9/-9 Primary endpoint: FU duration: | Rosenstock , 2006 | sitagliptin 100 mg once daily (n=-9) vs. placebo (n=-9) | patients with type 2 diabetes and inadequate glycemic control | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks |
|
diabetes type 2 | sitagliptin | not classified | versus biguanides No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Goldstein (sit vs met), 2007 | sitagliptin vs metformin | | | | Goldstein (sit+met vs met), 2007 | sitagliptin vs metformin | | | | Aschner, 2010 | sitagliptin monotherapy vs metformin | | | | Derosa , 2010 | sitagliptin+pio vs metformin+pio | | | |
Trial | Treatments | Patients | Method |
---|
Goldstein (sit vs met), 2007 | sitagliptin 100 dailyily (n=-9) vs. metformin 1000 mg or 2000 mg daily;imag (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Goldstein (sit+met vs met), 2007 | sitagliptin 50 mg daily plus metformin 1000 or 2000 mg dailyç$4 (n=-9) vs. metformin 1000 or 2000 mg daily (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Aschner, 2010 | once-daily sitagliptin 100 mg (n=528) vs. twice-daily metformin 1000 mg (n=522) | treatment-naïve patients with type 2 diabetes | double-blind Sample size: 528/522 Primary endpoint: FU duration: 24 weeks | Derosa , 2010 | pioglitazone 30 mg plus sitagliptin 100 mg once a day (n=-9) vs. pioglitazone 15 mg plus metformin 850 mg twice a day (n=-9) | poorly controlled type 2 diabetes mellitus patients | Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | sitagliptin | not classified | versus SU No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Scott* (sit vs glipi), 2007 | sitagliptin 50mg bid monotherapy vs glipizide | | | | Al Sifri, 2011 | sitagliptin vs Sulphonylurea (on top MET) | | | | Arechavaleta, 2011 | sitagliptin vs glimepiride (add on MET) | | | |
Trial | Treatments | Patients | Method |
---|
Scott* (sit vs glipi), 2007 | sitagliptin 50mg bid (n=-9) vs. glipizide 5mg to 20 mg dailyitm (n=-9) | patients with type 2 diabetes who have inadequate glycaemic control on diet and exercise | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks | Al Sifri, 2011 | sitagliptin 100 mg qd (n=507) vs. prestudy sulphonylurea (n=514) | Muslim patients with type 2 diabetes who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months | open Parallel groups Sample size: 507/514 Primary endpoint: FU duration: | Arechavaleta, 2011 | sitagliptin 100 mg daily (n=516) vs. glimepiride (starting dose 1 mg/day and up-titrated, based upon patient's self-monitoring of blood glucose results, to a maximum dose of up to 6 mg/day) (n=519) | patients with type 2 diabetes inadequately controlled on metformin monotherapy | double-blind Parallel groups Sample size: 516/519 Primary endpoint: FU duration: 30 weeks |
|
diabetes type 2 | sitagliptin | not classified | versus TZD No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Pérez-Monteverde, 2011 | sitagliptin vs pioglitazone | | | |
Trial | Treatments | Patients | Method |
---|
Pérez-Monteverde, 2011 | sitagliptin100 mg qd (n=-9) vs. pioglitazone 15 mg qd, up-titrated to 30 mg after 6 weeks (n=-9) | drug-naïve patients with type 2 diabetes | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks |
|
diabetes type 2 | vildagliptin | not classified | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Garber, 2008 | vildagliptin vs placebo (add on SU) | | | | NCT00101673 | vildagliptin vs | | | |
Trial | Treatments | Patients | Method |
---|
Garber, 2008 | vildagliptin (50 mg given once or twice daily) (n=515) vs. placebo (n=0) | patients with type 2 diabetes inadequately controlled with a sulphonylurea | double-blind Sample size: 515/0 Primary endpoint: FU duration: 24 weeks | NCT00101673 | vildagliptin (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | vildagliptin | not classified | versus alpha-glucosidase inhibitor No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Pan, 2008 | vildagliptin monotherapy vs acarbose | | | | NCT00368134 | vildagliptin vs voglibose | | | | Iwamoto, 2010 | vildagliptin vs voglibose | | | |
Trial | Treatments | Patients | Method |
---|
Pan, 2008 | vildagliptin (100 mg daily, given as 50 mg twice daily (n=441) vs. acarbose (up to 300 mg daily, given as three equally divided doses (n=220) | drug-naive patients with Type 2 diabetes | double-blind Sample size: 441/220 Primary endpoint: FU duration: 24 weeks | NCT00368134 | Vildagliptin 50 mg Bid (n=-9) vs. Voglibose 0.2 mg Tid (n=-9) | patients with type 2 diabetes | Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks | Iwamoto, 2010 | vildagliptin (50 mg bid, (n=188) vs. voglibose (0.2 mg tid (n=192) | Japanese patients with T2D who were inadequately controlled with diet and exercise | double-blind Sample size: 188/192 Primary endpoint: FU duration: 12 weeks |
|
diabetes type 2 | vildagliptin | not classified | versus placebo or control No demonstrated result for efficacy | 24 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Dejager [1], 2007 | vildagliptin monotherapy vs placebo | | | Adverse events leading to treatment discontinuation 1.01 [0.33; 3.07] | Mimori, 2006 | vildagliptin vs placebo | | | | Pi-Sunyer, 2007 | vildagliptin monotherapy vs placebo | Adverse events leading to treatment discontinuation 4.38 [1.29; 14.86] | | | Pratley, 2006 | vildagliptin monotherapy vs placebo | | | Adverse events leading to treatment discontinuation ∞ [NaN; ∞] | Ristic, 2005 | vildagliptin monotherapy vs placebo | | | Adverse events leading to treatment discontinuation 0.60 [0.10; 3.47] | Scherbaum [2], 2008 | vildagliptin vs placebo | | | Adverse events leading to treatment discontinuation 2.24 [0.89; 5.68] | Ahren, 2004 | vildagliptin vs placebo (add on MET) | | | Adverse events leading to treatment discontinuation NaN [NaN; NaN] | Bosi, 2007 | vildagliptin vs placebo (add on MET) | | | Adverse events leading to treatment discontinuation 1.73 [0.52; 5.81] | Fonseca, 2007 | vildagliptin vs placebo (add on insulin) | Adverse events leading to treatment discontinuation 9.50 [1.22; 74.05] | | | Garber, 2007 | vildagliptin vs placebo (on top pioglitazone) | | | Adverse events leading to treatment discontinuation 1.25 [0.34; 4.57] | Goodman, 2009 | vildagliptin vs placebo (add on MET) | | | all hypoglycemia ∞ [NaN; ∞] | Rosenstock, 2008 | vildagliptin vs placebo | | | | Bosi, 2009 | vildagliptin vs placebo (add on MET) | | | | Foley, 2011 | vildagliptin monotherapy vs placebo | | | | Kikuchi, 2009 | vildagliptin monotherapy vs placebo | | | | NCT00728351 | vildagliptin vs placebo (add on MET) | | | | Kikuchi, 2010 | vildagliptin vs placebo (add on glimepiride) | | | | NCT00822211 | vildagliptin vs placebo (add on MET) | | | | NCT00351832 | vildagliptin vs placebo | | | | NCT00494884 (Wollmer) | vildagliptin vs placebo (add on MET) | | | | Ahren, 2009 | vildagliptin monotherapy vs placebo | | | | NCT00396071 | vildagliptin vs placebo (add on MET) | | | | Lukashevich , 2011 | vildagliptin vs placebo (add on current therapy) | | | | Fonseca , 2008 | vildagliptin vs placebo (add on insulin) | | | |
Trial | Treatments | Patients | Method |
---|
Dejager [1], 2007 | vildagliptin 50 mg or 100 mg daily (n=-9) vs. placebo (n=-9) | drug-naïve patients with type 2 diabetes | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | Mimori, 2006 | vildagliptin 20 mg or 50 mg or 100 mg daily (n=-9) vs. placebo (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Pi-Sunyer, 2007 | vildagliptin 50 mg or 100 mg daily, imag (n=-9) vs. placebo (n=-9) | drug-naïve patients with type 2 diabetes | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | Pratley, 2006 | vildagliptin 25mg bid (n=70) vs. placebo (n=28) | | double-blind Sample size: 70/28 Primary endpoint: FU duration: | Ristic, 2005 | vildagliptin 25mg or 50mg or 100mg daily (n=-9) vs. placebo (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Scherbaum [2], 2008 | vildagliptin 50 mg qd (n=156) vs. placebo (n=150) | drug-naïve patients with type 2 diabetes and mild hyperglycaemia | double-blind Parallel groups Sample size: 156/150 Primary endpoint: FU duration: 52 weeks | Ahren, 2004 | vildagliptin 50 mg daily (add-on to metformin therapy)j (n=56) vs. placebo (add-on to metformin therapy)mag (n=51) | patients with type 2 diabetes | double-blind Sample size: 56/51 Primary endpoint: FU duration: 12 weeks | Bosi, 2007 | vildagliptin (50 or) 100 mg daily (add-on to metformin therapy)m (n=185) vs. placebo (add-on to metformin therapy)mag (n=182) | patients with type 2 diabetes inadequately controlled with metformin | double-blind Sample size: 185/182 Primary endpoint: FU duration: | Fonseca, 2007 | vildagliptin 100 mg daily (add-on to insulin therapy)y) (n=144) vs. placebo (add-on to insulin therapy)y)mag (n=152) | type 2 diabetes that was inadequately controlled by insulin | double-blind Sample size: 144/152 Primary endpoint: FU duration: 24 weeks | Garber, 2007 | vildagliptin 50 or 100 mg daily (add-on to pioglitazone therapy) (n=463) vs. placebo (add-on to pioglitazone therapy) (n=0) | | Sample size: 463/0 Primary endpoint: FU duration: | Goodman, 2009 | ildagliptin 100 mg given in the morning, vildagliptin 100 mg given in the evening (n=125) vs. placebo (n=122) | patients inadequately controlled with metformin | double-blind Parallel groups Sample size: 125/122 Primary endpoint: FU duration: 24 weeks | Rosenstock, 2008 | vildagliptin (50 mg q.d.) (n=-9) vs. placebo (n=-9) | subjects with impaired glucose tolerance | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks | Bosi, 2009 | vildagliptin plus high-dose metformin combination therapy (50 mg + 1000 mg twice daily), (n=1179) vs. high-dose metformin monotherapy (1000 mg twice daily). (n=0) | treatment-naive patients with type 2 diabetes mellitus | Sample size: 1179/0 Primary endpoint: FU duration: 24 weeks | Foley, 2011 | vildagliptin 100 mg (n=29) vs. placebo (n=30) | drug-naive patients with type 2 diabetes and mild hyperglycaemia | Sample size: 29/30 Primary endpoint: FU duration: | Kikuchi, 2009 | vildagliptin 50mg bid (n=-9) vs. placebo (n=-9) | Japanese patients with type 2 diabetes mellitus | Sample size: -9/-9 Primary endpoint: FU duration: | NCT00728351 | Vildagliptin and Metformin (25/1000 mg Bid) (n=-9) vs. Metformin Monotherapy (1000 mg Bid) (n=-9) | Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy | Sample size: -9/-9 Primary endpoint: FU duration: | Kikuchi, 2010 | vildagliptin 50mg twice-daily (n=102) vs. placebo (n=100) | Japanese patients with Type 2 diabetes mellitus | double-blind Sample size: 102/100 Primary endpoint: FU duration: 12 weeks | NCT00822211 | Vildagliptin 50 mg Bid or qd (n=-9) vs. placebo (n=-9) | Chinese Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | NCT00351832 | vildagliptin 50mg qd, 50mg bid or 100mg qd (n=-9) vs. placebo (n=-9) | Patients With Type 2 Diabetes | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks | NCT00494884 (Wollmer) | Vildagliptin 100 mg o.d. (n=-9) vs. placebo (n=-9) | Patients With Type 2 Diabetes Inadequately Controlled With Metformin | Sample size: -9/-9 Primary endpoint: FU duration: | Ahren, 2009 | vildagliptin (100 mg/d) (n=-9) vs. placebo (n=-9) | drug-naive patients with type 2 diabetes | Cross over Sample size: -9/-9 Primary endpoint: FU duration: | NCT00396071 | vildagliptin (n=-9) vs. placebo (n=-9) | Patients With Type 2 Diabetes Treated With Metformin | Cross over Sample size: -9/-9 Primary endpoint: FU duration: | Lukashevich , 2011 | vildagliptin (50 mg qd) (n=-9) vs. placebo (n=-9) | patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal impairment | Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | Fonseca , 2008 | vildagliptin added to insulin (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
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diabetes type 2 | vildagliptin | not classified | versus SU No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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Ferrannini, 2009 | vildagliptin vs Sulfonylurea (add on to MET) | all hypoglycemia 0.10 [0.07; 0.16] | | HbA1c goal <7% 0.97 [0.90; 1.05] | Filozof, 2009 | vildagliptin vs gliclazide (add on MET) | | | | Foley, 2009 | vildagliptin monotherapy vs gliclazide | | | | Matthews , 2010 | vildagliptin vs glimepiride (add on MET) | | | |
Trial | Treatments | Patients | Method |
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Ferrannini, 2009 | vildagliptin 50 mg twice daily (n=1396) vs. glimepiride titrated up to 6 mg/day (n=1393) | Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) | double-blind Parallel groups Sample size: 1396/1393 Primary endpoint: HbA1c FU duration: 52 weeks | Filozof, 2009 | vildagliptin (50 mg twice daily (n=513) vs. gliclazide (up to 320 mg/day (n=494)
| patients with Type 2 diabetes inadequately controlled with metformin
| double-blind Sample size: 513/494 Primary endpoint: FU duration: 52 weeks
| Foley, 2009 | monotherapy with vildagliptin 50 mg bid (n=-9) vs. gliclazide up to 320 mg/day (n=-9) | drug-naïve patients with type 2 diabetes | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 2 years | Matthews , 2010 | vildagliptin (n=-9) vs. glimepiride (n=-9) | patients with type 2 diabetes mellitus inadequately controlled (HbA1c 6.5-8.5%) by metformin monotherapy | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 2 years |
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diabetes type 2 | vildagliptin | not classified | versus biguanides No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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Schweizer, 2007 | vildagliptin vs metformin | | | Adverse events leading to treatment discontinuation 0.58 [0.30; 1.10] | Goke, 2008 | vildagliptin vs metformin | | | | Schweizer, 2009 | vildagliptin vs metformin | | | | CLAF237A 23104 | vildagliptin + MET vs MET | | | |
Trial | Treatments | Patients | Method |
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Schweizer, 2007 | vildagliptin 100mg (n=526) vs. metformin up to 2000 mg daily (n=254) | drug-naïve patients with Type 2 diabetes | Sample size: 526/254 Primary endpoint: FU duration: 52 weeks | Goke, 2008 | vildagliptin (100 mg daily) (n=-9) vs. metformin (2 000 mg daily). (n=-9) | drug-naïve patients with type 2 diabetes | Sample size: -9/-9 Primary endpoint: FU duration: | Schweizer, 2009 | vildagliptin (100 mg daily (n=169) vs. metformin (titrated to 1500 mg daily (n=166) | drug-naïve patients with type 2 diabetes aged>or=65 years | Sample size: 169/166 Primary endpoint: FU duration: | CLAF237A 23104 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
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diabetes type 2 | vildagliptin | not classified | versus TZD No demonstrated result for efficacy | 6 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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Rosenstock* (vilda vs rosi), 2007 | vildagliptin vs rosiglitazone | | | | Rosenstock** (vilda vs pio), 2007 | vildagliptin monotherapy vs pioglitazone | | | | Bolli, 2008 | vildagliptin vs pioglitazone (add on MET) | | | Adverse events leading to treatment discontinuation 0.95 [0.38; 2.36] | Rosenstock** (vilda + pio vs pio), 2007 | vildagliptin vs placebo (add on TZD) | | | Adverse events leading to treatment discontinuation 0.47 [0.15; 1.49] | GALIANT (Blonde), 2009 | vildagliptin vs TZD (add on MET) | | | | Rosenstock, 2009 | vildagliptin vs rosiglitazone | | | |
Trial | Treatments | Patients | Method |
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Rosenstock* (vilda vs rosi), 2007 | vildagliptin 100 mg daily daily (n=519) vs. rosiglitazone 8 mg once daily (n=267) | drug-naïve patients with type 2 diabetes | double-blind Sample size: 519/267 Primary endpoint: FU duration: 24 weeks | Rosenstock** (vilda vs pio), 2007 | vildagliptin 100 mg daily daily (n=-9) vs. pioglitazone 30 mg dailyaily (n=-9) | drug-naive patients with type 2 diabetes | double-blind Sample size: -9/-9 Primary endpoint: FU duration: | Bolli, 2008 | vildagliptin 100 mg daily (add-on to metformin therapy) (n=295) vs. pioglitazone 30 mg daily (add-on to metformin therapy)j (n=281) | patients with type 2 diabetes inadequately controlled with metformin monotherapy | double-blind Sample size: 295/281 Primary endpoint: FU duration: | Rosenstock** (vilda + pio vs pio), 2007 | vildagliptin 50 mg or 100 mg daily plus 15 mg or 30 mg pioglitazone dailyi (n=-9) vs. pioglitazone 30 mg daily (n=-9) | drug-naive patients with type 2 diabetes | double-blind Sample size: -9/-9 Primary endpoint: FU duration: 24 weeks | GALIANT (Blonde), 2009 | vildagliptin 100 mg (n=1653) vs. TZD (agent and dose at the investigators' discretion (n=825) | patients inadequately controlled [haemoglobin A(1C) (HbA(1c)): 7-10%] on a stable dose of metformin (> or =1000 mg/day). | Sample size: 1653/825 Primary endpoint: FU duration: | Rosenstock, 2009 | vildagliptin (50 mg b.i.d (n=396) vs. rosiglitazone (8 mg q.d., (n=202) | drug-naïve type 2 diabetes mellitus patients | double-blind Sample size: 396/202 Primary endpoint: FU duration: |
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