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

NCT01212133 | Completed

• 2 other identifiers: NN2211-3865U1111-1114-9324
• Study Type: observational
• Target: 1,386
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• The number of serious adverse drug reactions (SADRs) during the study period

  during 26 weeks of treatment

Secondary Outcomes (3)

• 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

• Frequency of hypoglycaemic episodes

  during 26 weeks of treatment

Study Arms (1)

A

Drug: liraglutide

Interventions

liraglutide DRUG

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

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with type 2 diabetes, including newly-diagnosed subjects, who are considered to need treatment with liraglutide are eligible for the study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bangalore, 560001, India

Location

Related 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 mellitus treated under routine clinical practice conditions in India. Indian J Endocrinol Metab. 2016 Nov-Dec;20(6):838-845. doi: 10.4103/2230-8210.189232.

  PMID: 27867889 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

IN (1)