Non-Interventional Study on Safety of Liraglutide in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— Lead-Ph  

Official title:

Liraglutide Effectiveness and Safety Data From Routine Clinical Practice in Philippines Study. A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes Mellitus in Philippines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345734
• Other study ID #: NN2211-3932
• Secondary ID: U1111-1119-8803
• Status: Completed
• Start date: September 1, 2011
• Est. completion date: July 26, 2013

Study information

• Verified date: December 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 this trial is to investigate the safety profile of liraglutide under normal conditions of use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1056
• Est. completion date: July 26, 2013
• Est. primary completion date: July 26, 2013
• 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 or those already receiving other anti-diabetic medications including GLP-1 analogues other than Liraglutide, who require treatment with liraglutide according to the clinical judgment of their treating physician

• Subjects who are capable of giving study-specific signed informed consent before any collection of information

Exclusion Criteria:

• Subjects with type 1 diabetes

• Subjects who are or have previously been on liraglutide

• Subjects who are participating in another clinical trial

• Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)

• Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Liraglutide will be prescribed and titrated by the treating physician and will be self-administered by the subject s.c. (under the skin) once daily. Study participants being treated with GLP-1 (Glucagon-Like Peptide 1)agonists or DDP-4-inhibitors (Dipeptidyl-peptidase 4 ) should stop treatment when initiating liraglutide treatment.

Locations

Country	Name	City	State
Philippines	Novo Nordisk Investigational Site	Manilla

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

The multicenter, open-label, observational LEAD-Ph study: real-world safety and effectiveness of liraglutide in Filipino participants with type 2 diabetes. Jimeno CA, Kho SA, de los Santos GK, Buena-Bobis NL, Villa M. J ASEAN 2018 [Epub ahead of print] DO

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse drug reactions (SADRs)		Week 0, week 26
Secondary	Incidence of adverse drug reactions (ADRs)		Week 0, week 26
Secondary	Incidence of serious adverse events (SAEs)		Week 0, week 26
Secondary	Frequency of hypoglycaemic episodes		Week 0, week 26
Secondary	Change in HbA1c (glycosylated haemoglobin)"		Week 0, week 26

External Links

•   Clinical Trials at Novo Nordisk