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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: July 21, 2011
Last updated: January 22, 2016
Last verified: January 2016
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 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:

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

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 ]

Enrollment: 4121
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


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®)

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01403025

Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01403025     History of Changes
Other Study ID Numbers: NN2211-3772  U1111-1120-7575  JapicCTI-111559 
Study First Received: July 21, 2011
Last Updated: January 22, 2016
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

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

ClinicalTrials.gov processed this record on May 26, 2016