Status:
COMPLETED
Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 dia...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus
- Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
- HbA1c: 7.0-10.0%
- Body Mass Index (BMI) no higher than 40.0 kg/m\^2
- For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)
Exclusion
- Treatment with exenatide or liraglutide within the last 3 months before trial start
- Cardiovascular disease within the last 6 months
- Uncontrolled treated/untreated severe hypertension
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
- Cancer and medical history of cancer
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
1030 Patients enrolled
Trial Details
Trial ID
NCT00982644
Start Date
September 1 2009
End Date
December 1 2010
Last Update
February 9 2017
Active Locations (187)
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1
Novo Nordisk Investigational Site
Bay Minette, Alabama, United States, 36507-4198
2
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35209
3
Novo Nordisk Investigational Site
Huntsville, Alabama, United States, 35801
4
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395