Liraglutide Safety and Effectiveness Data From Routine Clinical Practice in India (Lead-In) Study

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: liraglutide (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Prasanna Kumar, Study Director, Affiliation: Novo Nordisk India Private Ltd
Raman Shetty, Study Director, Affiliation: Novo Nordisk India Private Ltd

Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com

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.

Official title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: The number of serious adverse drug reactions (SADRs) during the study period

Secondary outcome:

The number of adverse drug reactions (ADR) during the study period

The number of serious adverse events (SAE) during the study period

Frequency of hypoglycaemic episodes

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com

Bangalore 560001, India

Clinical Trials at Novo Nordisk

Starting date: September 2010
Last updated: September 30, 2010