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:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01212133
First received: September 29, 2010
Last updated: June 19, 2012
Last verified: June 2012
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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:
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 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 |
ClinicalTrials.gov processed this record on May 23, 2013