Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00957060
- Lead Sponsor
- Sanofi
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description glimepiride GLIMEPIRIDE (HOE490) The initial dose is 2 mg once a day. At week 2, the dose can be increased to 4 mg once a day according to the titration. At week 4 and 12, the dose can be increased from 2 mg to 4 mg or from 4 mg to 6 mg according to the titration. sitagliptin SITAGLIPTIN 100 mg once a day. The dose will not be titrated.
- Primary Outcome Measures
Name Time Method HbA1c at baseline, week 12 and week 24 Fasting and postprandial glucose at baseline, week 2, 4, 12 and 24
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇲🇽Col. Coyoacan, Mexico