Comparison of NN5401 versus insulin glargine, both with metformin treatment, in subjects with type 2 diabetes
- Conditions
- Diabetes mellitus, Diabetes Mellitus, Type 2,
- Registration Number
- CTRI/2010/091/000044
- Lead Sponsor
- Novo Nordisk AS
- Brief Summary
The aim of this clinical trial is to compare NN5401 with insulin glargine, as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug) in subjects with type 2 diabetes.Trial Start Date in India:28 Jan 2010Subjects Enrolled in India:71Duration of trial: 26 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 526
- Diagnosis of type 2 diabetes mellitus for at least 6 months Insulin naïve subjects Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start HbA1c between 7.5 ?
- 11.0% (both inclusive) BMI (Body Mass Index) no higher than 40.0 kg/m2 Age 18 and older.
Treatment with GLP-1 receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start Cardiovascular disease diagnosed within 6 months before trial start.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c change From baseline after 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Plasma glucose profiles After 26 weeks of treatment
Trial Locations
- Locations (7)
Amrita Institute of Medical Sciences
🇮🇳Elamakkara, (P.O),, India
Diabetes Care & Research Centre
🇮🇳Patna, BIHAR, India
Diabetes, Thyroid & Research Centre
🇮🇳Jaipur, RAJASTHAN, India
Lina Diabetes Care Centre
🇮🇳Mumbai, MAHARASHTRA, India
Lotus Diagnostic Centre
🇮🇳Bangalore, KARNATAKA, India
Swamy Diabetes Centre
🇮🇳Chennai, TAMIL NADU, India
Trichy Diabetes Speciality Centre
🇮🇳Thillai, India
Amrita Institute of Medical Sciences🇮🇳Elamakkara, (P.O),, IndiaDr Unnikrishnan A.G.Principal investigatorunnikrishnanag@aims.amrita.edu