Phase 3
Completed N=365
Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Source: ClinicalTrials.gov NCT00316082 ↗Enrolled (actual)
365
Serious AEs
8.5%
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline in Hemoglobin A1 (A1C) at Week 24 — 8.04; 7.93; 8.02; 7.79 percent
Summary
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1 (A1C) at Week 24 |
8.04; 7.93; 8.02; 7.79; 7.30; 7.27 | — |
| SECONDARY Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM |
7.88; 7.79; 7.29; 7.57; -0.61; -0.26 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
156.6; 162.2; 170.6; 159.6; 158.6; 146.8 | — |
| SECONDARY Percentage of Participants Achieving A1C < 7% at Week 24 |
35.8; 44.9; 43.5; 38.6; 35.3 | — |
| SECONDARY Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 |
47432; 50417; 50032; 47078; 47640; 39798 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Inadequate blood sugar control
Exclusion Criteria
- Previous treatment for diabetes
- Current treatment with other medications to lower blood sugar
- Major heart, liver or kidney problems
- Women who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00316082). 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.