A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India (Lead-In)

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT01212133

U1111-1114-9324 (Other Identifier)

NN2211-3865

Details and patient eligibility

About

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.

Enrollment: 1,386 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,386 participants in 1 patient group

A

Treatment:

Drug: liraglutide