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Paid Diabetes Clinical Trial Now Enrolling at Achieve Clinical Research in Birmingham, Alabama; Accepting M/F Age 18+ with Type 2 Diabetes
Date:12/17/2012

efficacy, safety and convenience.

PRIMARY OBJECTIVE

To confirm superiority of insulin degludec/liraglutide versus unchanged glucagon-like peptide-1 (GLP-1) receptor agonist therapy in controlling glycaemia in insulin naïve subjects with type 2 diabetes mellitus (T2DM) inadequately controlled on GLP-1 receptor agonist therapy in combination with metformin.

SECONDARY OBJECTIVE

To compare general efficacy and safety of insulin degludec/liraglutide versus unchanged GLP-1 receptor agonist therapy in insulin naïve subjects with T2DM inadequately controlled with GLP-1 receptor agonist therapy in combination with metformin after 26 weeks of treatment.

TRIAL DESIGN

A 26-week, multi-center, multinational, open-label, 2-arm parallel, randomized, treat-to-target trial in insulin naïve subjects with T2DM inadequately controlled on a maximum tolerated dose or maximum dose according to local label of GLP-1 receptor agonist and metformin.

Subjects will be randomized in a 2:1 manner into one of the two treatment arms:

  • Once daily insulin degludec/liraglutide added to pre-trial dose of metformin therapy or
  • Unchanged pre-trial GLP-1 receptor agonist in combination with metformin

The randomization will be stratified according to pre-trial type of GLP-1 receptor agonist. The total duration of the trial is approximately 29 weeks consisting of 2 weeks screening period and 26 weeks treatment period and a follow-up visit 1 week after end of treatment. During the 26 week treatment period the subjects will have weekly contacts with the site.

KEY INCLUSION CRITERIA


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