| 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 | 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 | 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: |
|
| diabetes type 2 | vildagliptin | not classified | versus SU No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| 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 |
|---|
| 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 |
|
| diabetes type 2 | vildagliptin | not classified | versus biguanides No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| 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 |
|---|
| 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: |
|
| diabetes type 2 | vildagliptin | not classified | versus TZD No demonstrated result for efficacy | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| 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 |
|---|
| 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: |
|
