| 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: |
