A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2003-08-01

Summary

Primary objective:

• To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.

Secondary objectives:

• To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia.

• To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms.

• To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment.

• To obtain safety data on the use of insulin glargine in each treatment algorithm.

• To measure change in subject weight and insulin dose between baseline and end of treatment.

• To determine subject quality of life and treatment satisfaction (sub-study)

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine