Comparison of NN5401 with insulin glargine, both in combination with oral antidiabetic drugs, in subjects with type 2 diabetes
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Diabetes Mellitus, Type 2.
- Registration Number
- CTRI/2010/091/000022
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 450
Type 2 diabetes mellitus for at least 6 months
Ongoing daily treatment with a basal insulin (insulin detemir, insulin glargine, or insulin NPH) once daily for at least 3 months
Ongoing treatment with metformin with our without other OADs (oral anti-diabetic drugs) for at least 3 months
HbA1c 7.0 ? 10.0 % (both inclusive)
BMI (Body Mass Index) at most 40.0 kg/m2
Age 18 Years and older
Treatment with other insulin regimens than those listed in key inclusion criterion within the last 3 months
Treatment with rosiglitazone, or GLP-1 receptor agonists within the last 3 months
Significant 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
Impaired liver or renal function
Cancer and medical history of cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method