drugset / Trial / NCT00659477

Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2)

NCT00659477 ↗

Phase 4 Completed 117 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Aim of the study is to compare two treatment regimens (insulin Lantus as basal insulin vs insulin NPH) plus oral antidiabetics in type 2 diabetic patients and confirm superiority of insulin glargine. Comparison is focused on: blood glucose (BG) variability of the two treatment regimens, quality of diabetes compensation (HbA1c, FBG/Fasting blood glucose), body weight development, dose of insulin and occurrence of symptomatic hypoglycaemia and other adverse events.

Timeline

Start
2008-03
Primary completion
2009-06
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic — —