Phase 3
Completed N=858
52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Source: ClinicalTrials.gov NCT00575588 ↗Enrolled (actual)
858
Serious AEs
12.7%
Results posted
Sep 2010
Primary outcomePrimary: Hemoglobin A1c (HbA1c) Change From Baseline to Week 52 — 7.46; 7.53; 6.74; 6.71 Percent
Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c (HbA1c) Change From Baseline to Week 52 |
7.46; 7.53; 6.74; 6.71; -0.74; -0.80 | — |
| SECONDARY Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks |
3; 36.3 | <0.0001 sig |
| SECONDARY Body Weight Change From Baseline to Week 52 |
88.7; 88.6; 87.6; 89.7; -1.1; 1.1 | <0.0001 sig |
| SECONDARY Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c |
0.001; 0.004 | 0.040 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes,
- Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1,
- HbA1c >6.5% and ≤10.0%
Exclusion Criteria
- Type 1 diabetes,
- history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
- Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Data sourced from ClinicalTrials.gov (NCT00575588). 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.