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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403025
• Other study ID #: NN2211-3772
• Secondary ID: U1111-1120-7575J
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: February 9, 2018
• Start date: July 19, 2011
• Est. completion date: December 28, 2015

Study information

• Verified date: February 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4121
• Est. completion date: December 28, 2015
• Est. primary completion date: December 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• 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

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of SADRs (Serious Adverse Drug Reactions)		After 36 months
Secondary	The incidence rate and type of SAEs (Serious Adverse Events)		At month 1, 3, 6, 12, 24 and 36
Secondary	The incidence rate and type of ADRs (Adverse Drug Reactions)		At month 1, 3, 6, 12, 24 and 36

External Links

•   Clinical Trials at Novo Nordisk