drugset / Trial / NCT00957060

Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

NCT00957060

Phase 4 Completed 400 enrolled Sanofi
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

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule 2 mg Oral
Subject Glimepiride Small molecule 4 mg Oral
Comparator Sitagliptin Small molecule 100 mg Oral