At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 4 clinical trial evaluating Insulin glargine for Diabetes Mellitus, Type 2. Completed.
Detailed 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)