Comparison of NN1250 plus insulin Aspart with insulin Detemir plus insulin Aspart in type 1 diabetes.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type IHealth Condition 2: E10- Type 1 diabetes mellitus
- Registration Number
- CTRI/2010/091/000145
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
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/m2
Age 18 years and older
Exclusion Criteria
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
Cancer and medical history of cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method