EUCTR2009-011672-29-GB
Active, not recruiting
Phase 1
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
Conditionstype 1 diabetes mellitusMedDRA version: 12.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
DrugsLevemir
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- type 1 diabetes mellitus
- Sponsor
- ovo Nordisk A/S
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or females, age \= 18 years (\= 20 years for Japan)
- •Type 1 diabetes mellitus (diagnosed clinically) \= 12 months
- •Current treatment with any basal/bolus insulin regimen for at least 12 months prior to visit 1
- •HbA1c \= 10 % by central laboratory analysis
- •BMI \= 35\.0 kg/m²
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Use within the last 3 months prior to Visit 1 of any other antidiabetic glucose lowering drug than insulin
- •Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta\-blockers, MAO inhibitors
- •Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during the last 12 months) or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Previous participation in this trial. Participation is defined as randomised. Re\-screening of screening failures is allowed only once within the limits of the recruitment period
Outcomes
Primary Outcomes
Not specified
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