Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin
in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment
period.
Secondary objective was to assess the effect of insulin glargine in comparison with
sitagliptin on:
- HbA1c level
- Fasting Plasma Glucose (FPG)
- 7-point plasma glucose (PG) profiles
- Percentage of patients with HbA1c <7% and <6.5%
Safety objectives consisted of:
- Hypoglycemia occurrence
- Body weight
- Overall safety