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Non-Interventional Study on Safety of Liraglutide in Subjects With Type 2 Diabetes (Lead-Ph)

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ClinicalTrials.gov Identifier: NCT01345734
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide

Study Type : Observational
Actual Enrollment : 1056 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 1, 2011
Actual Primary Completion Date : July 26, 2013
Actual Study Completion Date : July 26, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Group/Cohort Intervention/treatment
Liraglutide 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.




Primary Outcome Measures :
  1. Incidence of serious adverse drug reactions (SADRs) [ Time Frame: Week 0, week 26 ]

Secondary Outcome Measures :
  1. Incidence of adverse drug reactions (ADRs) [ Time Frame: Week 0, week 26 ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Week 0, week 26 ]
  3. Frequency of hypoglycaemic episodes [ Time Frame: Week 0, week 26 ]
  4. Change in HbA1c (glycosylated haemoglobin)" [ Time Frame: Week 0, week 26 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345734


Locations
Philippines
Novo Nordisk Investigational Site
Manilla, Philippines, 1605
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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] DOI: 10.15605/jafes.033.02.02

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01345734     History of Changes
Other Study ID Numbers: NN2211-3932
U1111-1119-8803 ( Other Identifier: WHO )
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists