Phase 3
Completed N=801
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
Source: ClinicalTrials.gov NCT00666458 ↗Enrolled (actual)
801
Serious AEs
1.5%
Results posted
Apr 2010
Primary outcomePrimary: Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 — 7.68; 7.69; 7.16; 7.07 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 sitagliptin in addition with metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 |
7.68; 7.69; 7.16; 7.07; -0.52; -0.62 | — |
| SECONDARY Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 |
26.3; 29.1 | — |
| SECONDARY Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) |
159.67; 160.22; 149.04; 143.94; -10.75; -16.16 | — |
| SECONDARY Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) |
8.86; 8.89; 8.27; 7.99; -0.60; -0.90 | — |
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
Exclusion Criteria
- Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- Insulin therapy within one year
- Previous treatment with DPP-4 inhibitor
Data sourced from ClinicalTrials.gov (NCT00666458). 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.