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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01345734
Acronym
Lead-Ph
Enrollment
1056
Registered
2011-05-02
Start date
2011-09-01
Completion date
2013-07-26
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief 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.

Interventions

DRUGliraglutide

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.

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of serious adverse drug reactions (SADRs)Week 0, week 26

Secondary

MeasureTime frame
Incidence of adverse drug reactions (ADRs)Week 0, week 26
Incidence of serious adverse events (SAEs)Week 0, week 26
Frequency of hypoglycaemic episodesWeek 0, week 26
Change in HbA1c (glycosylated haemoglobin)Week 0, week 26

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026