Status:
COMPLETED
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-84 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglut...
Eligibility Criteria
Inclusion
- Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator
- HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
- HbA1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea
Exclusion
- Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator)
- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening
- Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
- Impaired kidney function
- Impaired liver function
- Uncontrolled treated/untreated hypertension
- Cancer or any clinically significant disease or disorder as judged by the Investigator
- Previous participation in the run-in phase of this trial. Re-screening is allowed once
- History of chronic pancreatitis or idiopathic pancreatitis
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
987 Patients enrolled
Trial Details
Trial ID
NCT00856986
Start Date
March 1 2009
End Date
November 1 2010
Last Update
March 8 2017
Active Locations (233)
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1
Novo Nordisk Investigational Site
Alexander City, Alabama, United States, 35010
2
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35294
3
Novo Nordisk Investigational Site
Encino, California, United States, 91436
4
Novo Nordisk Investigational Site
Fullerton, California, United States, 92835