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

A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating and Maintaining Lantus® (Insulin Glargine) Therapy Based on a Comparison of Two Treatment Algorithms to Determine Optimal Metabolic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus.

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)

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.