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

Diabetes Mellitus, Type 2 Clinical Trial

— Lead-In  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212133
• Other study ID #: NN2211-3865
• Secondary ID: U1111-1114-9324
• Status: Completed
• Phase: N/A
• First received: September 29, 2010
• Last updated: December 15, 2016
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1386
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Self-administered subcutaneously (under the skin) once daily at any time, independent of meals, in the abdomen, thigh or upper arm.

Locations

Country	Name	City	State
India	Novo Nordisk Investigational Site	Bangalore

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

India, 

References & Publications (1)

Wangnoo SK, Kumar S, Bhattacharyya A, Tripathi S, Akhtar S, Shetty R, Ghosal S. Liraglutide effect and action in diabetes-In (LEAD-In): A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of serious adverse drug reactions (SADRs) during the study period		during 26 weeks of treatment	Yes
Secondary	The number of adverse drug reactions (ADR) during the study period		during 26 weeks of treatment	Yes
Secondary	The number of serious adverse events (SAE) during the study period		during 26 weeks of treatment	Yes
Secondary	Frequency of hypoglycaemic episodes		during 26 weeks of treatment	Yes

External Links

•   Clinical Trials at Novo Nordisk