Status:
COMPLETED
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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,...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2009
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT00696657
Start Date
June 3 2008
End Date
February 5 2009
Last Update
August 14 2019
Active Locations (77)
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1
Novo Nordisk Investigational Site
Gratwein, Austria, 8112
2
Novo Nordisk Investigational Site
Graz, Austria, 8036
3
Novo Nordisk Investigational Site
Innsbruck, Austria, 6020
4
Novo Nordisk Investigational Site
Mödling, Austria, 2340