The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
NCT00856986 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 987
Last updated 2017-03-08
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 liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.
Conditions
- Diabetes
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.
- DRUG
-
insulin detemir
Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm
- DRUG
-
Metformin tablets, at least 1500 mg/day
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 84 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2010-04-30
- Completion
- 2010-11-30
Countries
- United States
- Belgium
- Canada
- France
- Germany
- Italy
- Netherlands
- Puerto Rico
- Spain
- United Kingdom
Study Locations
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