A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

• Status: Completed
• Trial end date: 2009-02-05
• Target enrollment: 0
• Participant gender: All

Summary

This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months

• Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months

• HbA1c: 7.0-10.0 % (both inclusive)

• Body weight between 60 kg and 110 kg

Exclusion Criteria:

• Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months

• Impaired liver or kidney function

• Proliferative retinopathy or maculopathy requiring acute treatment

• Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension

• Recurrent major hypoglycaemia or hypoglycaemic unawareness

• Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)