Status:
COMPLETED
Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspa...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus for at least 12 months
- Current treatment with any basal bolus insulin for at least 12 months
- HbA1c below or equal to 10.0%
- BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
- For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)
Exclusion
- Use of any other antidiabetic drug than insulin within the last 3 months
- Cardiovascular disease within the last 6 months
- Uncontrolled treated/untreated severe hypertension
- Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- Cancer and medical history of cancer
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2010
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT00982228
Start Date
September 1 2009
End Date
November 8 2010
Last Update
April 6 2017
Active Locations (91)
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1
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35209
2
Novo Nordisk Investigational Site
Huntsville, Alabama, United States, 35801
3
Novo Nordisk Investigational Site
Peoria, Arizona, United States, 85381
4
Novo Nordisk Investigational Site
Concord, California, United States, 94520