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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01403025
First received: July 21, 2011
Last updated: April 24, 2014
Last verified: April 2014

July 21, 2011
April 24, 2014
July 2011
July 2016   (final data collection date for primary outcome measure)
The incidence of SADRs (Serious Adverse Drug Reactions) [ Time Frame: After 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01403025 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes
A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: liraglutide
Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm
Liraglutide
Intervention: Drug: liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
July 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01403025
NN2211-3772, U1111-1120-7575, JapicCTI-111559
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP