Phase 3
Completed N=1,306
A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Source: ClinicalTrials.gov NCT00327015 ↗Enrolled (actual)
1,306
Serious AEs
5.3%
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy — 9.41; 9.53; 9.61; 6.93 percent
Summary
The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy |
9.41; 9.53; 9.61; 6.93; 7.02; 7.86 | — |
| PRIMARY Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy |
9.41; 9.53; 9.43; 6.93; 7.02; 7.48 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy |
198.9; 204.3; 200.9; 140.2; 140.1; 169.9 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy |
198.9; 204.3; 199.1; 140.2; 140.1; 152.7 | — |
| SECONDARY Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy |
60.3; 59.7; 32.2 | — |
| SECONDARY Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy |
60.3; 59.7; 41.1 | — |
| SECONDARY Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy |
55531; 57219; 57584; 35324; 35790; 41229 | — |
| SECONDARY Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy |
55531; 57219; 57937; 35324; 35790; 42428 | — |
| SECONDARY Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy |
45.3; 40.6; 20.3 | — |
| SECONDARY Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy |
45.3; 40.6; 29.0 | — |
| SECONDARY Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy |
7.5; 5.9; 21.2 | — |
| SECONDARY Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy |
7.5; 5.9; 10.1 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Inadequate blood sugar control
- No current treatment with other medications to lower blood sugar
Exclusion Criteria
- Major heart, liver or kidney problems
- Pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT00327015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.