Phase 3
Completed N=1,035
A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
Type 2 Diabetes Mellitus, Non Insulin Dependent · Diabetes Mellitus, Non-Insulin-Dependent
Source: ClinicalTrials.gov NCT00701090 ↗
Enrolled (actual)
1,035
Serious AEs
2.6%
Results posted
Oct 2010
Primary outcomePrimary: Change From Baseline in HbA1c at Week 30 — -0.47; -0.54 Percent
Summary
A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 30 |
-0.47; -0.54 | — |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 |
-14.6; -17.5 | — |
| SECONDARY Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 |
7.0; 22.0 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Week 30 |
-0.8; 1.2 | <0.001 sig |
| SECONDARY Percent of Patients With A1C <7.0% at Week 30 |
52.4; 59.6 | — |
| SECONDARY Percent of Patients With A1C <6.5% at Week 30 |
21.2; 27.5 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Diagnosed with type 2 diabetes
- On a stable dose of metformin of at least 1500 mg per day
Exclusion Criteria
- History of type 1 diabetes
- Pregnant
- HIV positive
- On a weight loss program or medication
- Has a history of blood disorder, certain cancers, heart, liver or kidney disease
Data sourced from ClinicalTrials.gov (NCT00701090). 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.