| pathology | Demonstrated benefit and harm | k | | | |
|---|
| diabetes type 2 | 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 | 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 | 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 |
|
