A trial, in which subjects with type 2 diabetes, who qualify for treatment intensification, are given insulin degludec and, additionally, either liraglutide or insulin aspart, both in combination with metformin, with the largest meal. The purpose is to compare efficacy and safety of these two treatments.
- Conditions
- Type 2 diabetesTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]MedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2011-001493-25-DE
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
- The subject must have completed the end of treatment visit of NN1250-3643 with IDeg OD + metformin.
- Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
- Participated in NN1250-3643 and treated with IGlar + metformin +/- DPP-IV inhibitor or IDeg + metformin + DPP-IV inhibitor
- Previous treatment with glucacon like peptide 1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
- Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times the upper limit of normal at end of treatment in NN1250-3643
- Impaired renal function defined as serum-creatinine = 125 µmol/L (= 1.4 mg/dL) for males and = 110 µmol/L (= 1.3 mg/dL) for females, at end of treatment in NN1250-3643
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of adding liraglutide versus adding IAsp to the largest meal on top of IDeg OD + metformin in controlling glycaemia.;Secondary Objective: To compare the safety of adding liraglutide versus adding IAsp to the largest meal on top of IDeg OD + metformin.;Primary end point(s): Change from baseline in HbA1c (%) after 26 weeks of treatment (analysed by central laboratory).;Timepoint(s) of evaluation of this end point: after 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Change from baseline in fasting plasma glucose (FPG) after 26 weeks<br>2- Change from baseline in body weight after 26 weeks<br>3- Number of severe and minor treatment emergent hypoglycaemic episodes that have onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product;Timepoint(s) of evaluation of this end point: 1 - after 26 weeks<br>2 - after 26 weeks<br>3 - one week after end of treatment in this trial, week 29 at the latest