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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01212133
First received: September 29, 2010
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • The number of serious adverse drug reactions (SADRs) during the study period [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of adverse drug reactions (ADR) during the study period [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]
  • The number of serious adverse events (SAE) during the study period [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Frequency of hypoglycaemic episodes [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 1386
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: liraglutide
Self-administered subcutaneously (under the skin) once daily at any time, independent of meals, in the abdomen, thigh or upper arm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212133

Locations
India
Bangalore, India, 560001
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Prasanna Kumar Novo Nordisk India Private Ltd
Study Director: Raman Shetty Novo Nordisk India Private Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01212133     History of Changes
Other Study ID Numbers: NN2211-3865, U1111-1114-9324
Study First Received: September 29, 2010
Last Updated: June 19, 2012
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014