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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.

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Trial Profile

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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2020

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At a glance

  • Drugs Liraglutide (Primary) ; Glimepiride; Insulin glargine; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms LEAD-5
  • Sponsors Novo Nordisk

Most Recent Events

  • 14 Jul 2016 Results of a meta-analysis in African-American/black people with T2DM from seven phase III trials (NCT00395746, NCT00614120, NCT00294723, NCT00333151, NCT00331851, NCT00518882 and NCT00700817), published in the Diabetic Medicine
  • 02 Nov 2012 Planned number of patients changed from 570 to 1036 as reported by European Clinical Trials Database record
  • 19 Jun 2012 Additional location added as reported by ClinicalTrials.gov.

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