Comparison of NN5401 with biphasic insulin aspart 30 in type 2 diabetes
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Diabetes Mellitus, Type 2
- Registration Number
- CTRI/2009/091/000462
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 117
Type 2 diabetes mellitus for at least 6 months
--Ongoing daily treatment with premixed human or analogue insulin or self-mixed insulin regimen, containing fast/rapid-acting component once or twice a day with or without metformin, SU, glinides, alpha-glucosidase inhibitor, DPP-4 inhibitor and pioglitazone for at least 3 months
--HbA1c: 7.0 - 10.0% (both inclusive)
--Body Mass Index (BMI) below or equal to 40.0 kg/m2
--Age 18 years and older
--Treatment with other insulin regimens than those listed in key inclusion criterion no. 2 within 3 months
--Treatment with rosiglitazone or GLP-1 receptor agonists within 3 months
--Cardiovascular disease, within the last 6 months
--Uncontrolled treated/untreated severe hypertension
--Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
--Cancer and medical history of cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c change from baseline after 26 weeks<br>of treatmentTimepoint: 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Hypoglycaemic episodesTimepoint: After 26 weeks of<br>treatment;Plasma glucose profilesTimepoint: after 26 weeks of<br>treatment