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Completed

NCT Number: NCT01212133

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Bangalore, 560001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Primary outcomes

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

    Time frame: during 26 weeks of treatment

Secondary outcomes

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

    Time frame: during 26 weeks of treatment

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

    Time frame: during 26 weeks of treatment

  3. Frequency of hypoglycaemic episodes

    Time frame: during 26 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: Lead-In

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 30, 2010
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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