Phase 3
Completed N=467
Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Source: ClinicalTrials.gov NCT00121641 ↗Enrolled (actual)
467
Serious AEs
11.8%
Results posted
May 2011
Primary outcomePrimary: Hemoglobin A1c (A1C) Changes From Baseline at Week 24 — 7.91; 7.98; 7.85; 7.88 Percentage of glycosylated hemoglobins — p=<.0001
Summary
The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c (A1C) Changes From Baseline at Week 24 |
7.91; 7.98; 7.85; 7.88; -0.43; -0.46 | <.0001 sig |
| PRIMARY A1C Changes From Baseline at Week 24 - Open Label Cohort |
10.70; -1.87 | — |
| SECONDARY Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) |
177.72; 171.31; 176.51; 171.85; -14.53; -8.67 | 0.0002 sig |
| SECONDARY Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 |
35.0; 37.9; 41.1; 23.9 | 0.1141 |
| SECONDARY Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) |
45030; 45691; 44614; 46030; -6868; -6896 | 0.0003 sig |
| SECONDARY Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort |
241.08; -33.42 | — |
| SECONDARY Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort |
14.1 | — |
| SECONDARY Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort |
60687; -11078 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Drug naive
- Hemoglobin (Hb) A1c >= 7.0% and 10% and = 1 ng/mL
- Body mass index = 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing Potential
Data sourced from ClinicalTrials.gov (NCT00121641). 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.