Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-5)
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This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.
Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Type 2 diabetes
Treatment with oral anti-diabetic drugs for at least 3 months
HbA1c: 7.5-10.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy.
Body Mass Index (BMI) less than or equal to 45 kg/m2
Treatment with insulin within the last 3 months
Treatment with any drug that could interfere with the glucose level
Any serious medical condition
Females who are pregnant, have intention of becoming pregnant or are breastfeeding