A trial comparing efficacy and safety of NN1250 and insulin glargine in subjects with type 2 diabetes
- Conditions
- type 2 diabetes mellitusMedDRA version: 12.0Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2009-010662-28-IE
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
• Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days).
• Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, a-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated:
- Metformin: alone or in combination (including fixed combination) 1500 mg daily, or
maximum tolerated dose (at least 1000 mg daily)
- Insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling
- DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling
- a-glucosidase-inhibitors (Acarbose): minimum half of the daily maximal dose or maximum tolerated dose
• HbA_1c 7.0-10.0 % (both inclusive) by central laboratory analysis
• BMI = 45.0 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
• Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs), exenatide or liraglutide
• Anticipated change in concomitant medication known to interfere significantly with glucose
metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors
• 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
• Known or suspected allergy to any of the trial products or related products
• Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method