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Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01403025
First received: July 21, 2011
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
 Drug: liraglutide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Drug Information available for: Liraglutide
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • The incidence of SADRs (Serious Adverse Drug Reactions) [ Time Frame: After 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence rate and type of SAEs (Serious Adverse Events) [ Time Frame: At month 1, 3, 6, 12, 24 and 36 ] [ Designated as safety issue: No ]
  • The incidence rate and type of ADRs (Adverse Drug Reactions) [ Time Frame: At month 1, 3, 6, 12, 24 and 36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Liraglutide Drug: liraglutide
Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who are considered to need treatment with liraglutide (Victoza®)

Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide

Exclusion Criteria:

  • Subjects who are or have previously been on liraglutide
  • Subjects who have previously been enrolled in the study
  • Subjects with a hypersensitivity to liraglutide or to any of the excipients
  • Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
  • Subjects with cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial
  • Known or suspected abuse of alcohol or narcotics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403025

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Senda Masayuki, PMS Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01403025     History of Changes
Other Study ID Numbers: NN2211-3772, U1111-1120-7575, CTI-111559
Study First Received: July 21, 2011
Last Updated: March 26, 2013
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

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 19, 2013