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

NCT01345734 | Completed

• 2 other identifiers: NN2211-3932U1111-1119-8803
• Study Type: observational
• Target: 1,056
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse drug reactions (SADRs)

  Week 0, week 26

Secondary Outcomes (4)

• Incidence of adverse drug reactions (ADRs)

  Week 0, week 26

• Incidence of serious adverse events (SAEs)

  Week 0, week 26

• Frequency of hypoglycaemic episodes

  Week 0, week 26

• Change in HbA1c (glycosylated haemoglobin)"

  Week 0, week 26

Study Arms (1)

Liraglutide

Drug: liraglutide

Interventions

liraglutide DRUG

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.

Liraglutide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with type 2 diabetes, including newly-diagnosed subjects or those already receiving other anti-diabetic medications including GLP-1 analogues other than liraglutide.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Manila, 1605, Philippines

Location

Related Publications (1)

• Jimeno C, Kho S, de Los Santos GK, Buena-Bobis N, Villa M. The Multicenter, Open-Label, Observational LEAD-Ph Study: Real-World Safety and Effectiveness of Liraglutide in Filipino Participants with Type 2 Diabetes. J ASEAN Fed Endocr Soc. 2018;33(2):114-123. doi: 10.15605/jafes.033.02.02. Epub 2018 Oct 9.

  PMID: 33442116 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 2, 2011
• Study Start: September 1, 2011
• Primary Completion: July 26, 2013
• Study Completion: July 26, 2013
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

PH (1)