drugset / Trial / NCT00957060
Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: To determine the superiority of glimepiride over sitagliptin in the reduction of HbA1c after 6 months of treatment in patients with monotherapy until the end of the trial. Secondary Objective: To evaluate the effect of glimepiride compared to sitagliptin in: Glucose in fasting conditions; Postprandial glucose; Percentage of patients with HbA1c \< 7% and \< 6.5%; Symptomatic Hypoglycemia; Body weight; Percentage of withdrawal and percentage of patients with rescue therapy; Safety (adverse events and serious adverse events, hypoglycemia, vital signs and laboratory results).
Timeline
- Start
- 2009-07
- Primary completion
- 2010-10
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glimepiride | Small molecule | 2 mg | Oral |
| Subject | Glimepiride | Small molecule | 4 mg | Oral |
| Comparator | Sitagliptin | Small molecule | 100 mg | Oral |