Status:
COMPLETED
Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in 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 Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) pl...
Eligibility Criteria
Inclusion
- For MAIN period (NN1250-3582):
- Type 2 diabetes mellitus for at least 6 months
- Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start
- HbA1c 7.0-10.0 % (both inclusive)
- Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
- For EXTENSION period (NN1250-3667):
- Completion of the 52 week treatment period in NN1250-3582
Exclusion
- For MAIN period (NN1250-3582):
- Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
- 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 :
October 28 2010
Estimated Enrollment :
1006 Patients enrolled
Trial Details
Trial ID
NCT00972283
Start Date
September 1 2009
End Date
October 28 2010
Last Update
April 6 2017
Active Locations (136)
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1
Novo Nordisk Investigational Site
Alexander City, Alabama, United States, 35010
2
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35209
3
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
4
Novo Nordisk Investigational Site
Peoria, Arizona, United States, 85381