Comparison of the efficacy and safety of two different dose adjustment regimens for insulin degludec/insulin aspart in subjects with type 2 diabetes mellitus previously treated with insulin glargine
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-000373-23-DE
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
- Age = 18 years
- Type 2 diabetes (diagnosed clinically) for = 24 weeks prior to Visit 2 (randomisation)
- Currently treated with IGlar and up to 3 OADs (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor) - All antidiabetic treatments should have been ongoing for =12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
- HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
- Body mass index (BMI) = 40 kg/m^2
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
- Uncontrolled or untreated severe hypertension defined as systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
- Life-threatening disease (e.g. cancer)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the efficacy of the insulin degludec/insulin aspart (IDegAsp) twice daily (BID) simple titration algorithm in controlling glycaemia with respect to change from baseline in glycosylated haemoglobin (HbA1c) after 26 weeks of treatment.;Secondary Objective: - To compare the efficacy of the IDegAsp BID simple titration algorithm versus IDegAsp BID stepwise titration algorithm after 26 weeks of treatment in terms of other measurements of glycaemic control<br>- To compare the safety of the IDegAsp BID simple titration algorithm versus IDegAsp BID stepwise titration algorithm after 26 weeks of treatment;Primary end point(s): Change from baseline in HbA1c (%) ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method