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 regime

Phase 1

• Conditions: type 1 diabetes mellitus; MedDRA version: 12.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus

• Registration Number: EUCTR2009-011672-29-GB
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-15
• Study Completion: 2010-12-08
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified