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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 : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

April 29, 2011
May 2, 2011
November 13, 2015
June 2011
July 2013   (Final data collection date for primary outcome measure)
Incidence of serious adverse drug reactions (SADRs) [ Time Frame: Week 0, week 26 ]
Same as current
Complete list of historical versions of study NCT01345734 on ClinicalTrials.gov Archive Site
  • Incidence of adverse drug reactions (ADRs) [ Time Frame: Week 0, week 26 ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Week 0, week 26 ]
  • Frequency of hypoglycaemic episodes [ Time Frame: Week 0, week 26 ]
  • Change in HbA1c (glycosylated haemoglobin)" [ Time Frame: Week 0, week 26 ]
Same as current
Not Provided
Not Provided
 
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
This trial is conducted in Asia. The aim of this trial is to investigate the safety profile of liraglutide under normal conditions of use.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • Diabetes
  • Diabetes Mellitus, Type 2
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.
Liraglutide
Intervention: Drug: liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1056
1000
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
 
NCT01345734
NN2211-3932
U1111-1119-8803 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2015