Phase 3
Completed N=768
A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
Source: ClinicalTrials.gov NCT00313313 ↗Enrolled (actual)
768
Serious AEs
6.9%
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 — 8.36; 8.48; 8.44; 7.83 percent
Summary
The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (A1C) at Week 24 |
8.36; 8.48; 8.44; 7.83; 7.83; 8.52 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
170.1; 175.0; 174.4; 164.4; 164.6; 174.6 | — |
| SECONDARY Percentage of Participants Achieving A1C < 7% at Week 24 |
22.4; 22.8; 9.1 | — |
| SECONDARY Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 |
49124; 50342; 51801; 45402; 45391; 52416 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes.
- Treated with a sulfonylurea for at least 2 months.
- Inadequate blood sugar control.
- Are not on any other medications to lower blood sugar.
- No major heart, liver or kidney problems.
- Women not pregnant or breast feeding.
Data sourced from ClinicalTrials.gov (NCT00313313). 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.