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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion criteria:

• Subjects with Type 2 Diabetes Mellitus,

• Subjects on antidiabetic treatment (oral and/or insulin therapy) for > 6 months,

• Subjects who require a basal long-acting insulin for the control of hyperglycaemia,

• HbA1c values > 7.0% and < 12 %,

• BMI < 40 kg/m².

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.