Phase 3
Completed N=570
Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00661362 ↗Enrolled (actual)
570
Serious AEs
1.9%
Results posted
Mar 2012
Primary outcomePrimary: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) — 7.90; 7.94; 7.10; 7.55 percent — p=<0.0001
Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) |
7.90; 7.94; 7.10; 7.55; -0.78; -0.37 | <0.0001 sig |
| SECONDARY Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L |
8.57; 8.87; 7.61; 8.30; -1.14; -0.58 | <0.0002 sig |
| SECONDARY Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL |
154.54; 159.73; 137.15; 149.54; -20.52; -10.42 | <0.0002 sig |
| SECONDARY Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup |
42423; 43719; 37071; 40521; -5673; -2871 | 0.0052 sig |
| SECONDARY Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup |
42423; 43719; 37071; 40521; -5673; -2871 | 0.0052 sig |
| SECONDARY Proportion of Patients Achieving a Therapeutic Glycemic Response |
46.5; 30.5 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Type 2 diabetes
- Treatment with metformin at a stable dose >1500 mg/day
- HbA1c ≥ 7.0% and ≤10.0%
Exclusion Criteria
- Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
- Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma
Data sourced from ClinicalTrials.gov (NCT00661362). 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.