A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India
- Registration Number
- NCT01212133
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Asia. The aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1386
Inclusion Criteria
- Subjects with type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including GLP-1 analogues, who require treatment with liraglutide according to the clinical judgment of their treating physician
- Subjects who are capable of giving study-specific signed informed consent before any collection of information
Exclusion Criteria
- Subjects with type 1 diabetes
- Subjects who are or have previously been on liraglutide
- Subjects who have previously been enrolled in the study
- Subjects who are participating in another clinical trial
- Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
- Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A liraglutide -
- Primary Outcome Measures
Name Time Method The number of serious adverse drug reactions (SADRs) during the study period during 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Frequency of hypoglycaemic episodes during 26 weeks of treatment The number of adverse drug reactions (ADR) during the study period during 26 weeks of treatment The number of serious adverse events (SAE) during the study period during 26 weeks of treatment
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇮🇳Bangalore, India