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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403025
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date July 21, 2011
First Posted Date July 27, 2011
Last Update Posted Date February 12, 2018
Actual Study Start Date July 19, 2011
Actual Primary Completion Date December 28, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 26, 2011)
The incidence of SADRs (Serious Adverse Drug Reactions) [ Time Frame: After 36 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 26, 2011)
  • The incidence rate and type of SAEs (Serious Adverse Events) [ Time Frame: At month 1, 3, 6, 12, 24 and 36 ]
  • The incidence rate and type of ADRs (Adverse Drug Reactions) [ Time Frame: At month 1, 3, 6, 12, 24 and 36 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes
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
Brief Summary 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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®)
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention Drug: liraglutide
Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm
Study Groups/Cohorts Liraglutide
Intervention: Drug: liraglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 17, 2014)
4121
Original Estimated Enrollment
 (submitted: July 26, 2011)
3000
Actual Study Completion Date December 28, 2015
Actual Primary Completion Date December 28, 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01403025
Other Study ID Numbers NN2211-3772
U1111-1120-7575 ( Other Identifier: WHO )
JapicCTI-111559 ( Registry Identifier: JAPIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2018