A trial is to compare the efficacy and safety of NN5401 insulin degludec and insulin aspartIDegAsp with insulin glargine IGlar both as add on to subjects ongoing treatment with metformin and at least one OAD oral anti diabetic drug
- Conditions
- Type 2 diabetes mellitus,
- Registration Number
- CTRI/2010/091/000623
- Lead Sponsor
- Novo Nordisk AS
- Brief Summary
The first enrollement of patients in India is 19 Aug 2010 The number of patients to be recruited in India is 38 Duration of the trial is 28 weeks Duration of treatment with trial product is 26 weeks This is an extension of trial of NN5401-3590 Trial ( Ref: CTRI/2010/091/000044).The study is completed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 360
- Informed consent obtained before any trial-related activities.
- Minimum 18years of age -Must have completed the 26-week treatment period (Visit 28) in trial NN5401-3590.
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors-Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)-Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of treatment emergent adverse events (AEs) after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3590 + 26 weeks of treatment in extension)
- Secondary Outcome Measures
Name Time Method Number of severe and minor treatment emergent hypoglycaemic episodes after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3590 + 26 weeks of treatment in extension)
Trial Locations
- Locations (7)
Amrita Institute of Medical Sciences
🇮🇳Ernakulam, KERALA, 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
🇮🇳Tiruchirappalli, TAMIL NADU, India
Amrita Institute of Medical Sciences🇮🇳Ernakulam, KERALA, IndiaDr Unnikrishnan AGPrincipal investigator04842802084unnikrishnanag@aims.amrita.edu