CTRI/2010/091/000145
Completed
Phase 3
A trial investigating the efficacy and safety of NN1250 compared to insulin detemir in subjects with type 1 diabetes mellitus in a basal/bolus treatment regimen (BEGIN?: BB T1)
ovo Nordisk AS0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovo Nordisk AS
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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