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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date April 29, 2011
First Posted Date May 2, 2011
Last Update Posted Date December 11, 2018
Actual Study Start Date September 1, 2011
Actual Primary Completion Date July 26, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2011)
Incidence of serious adverse drug reactions (SADRs) [ Time Frame: Week 0, week 26 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01345734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 29, 2011)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Interventional Study on Safety of Liraglutide in Subjects With Type 2 Diabetes
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Diabetes
  • 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.
Study Groups/Cohorts Liraglutide
Intervention: Drug: liraglutide
Publications * 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 19, 2014)
1056
Original Estimated Enrollment
 (submitted: April 29, 2011)
1000
Actual Study Completion Date July 26, 2013
Actual Primary Completion Date July 26, 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries  
 
Administrative Information
NCT Number NCT01345734
Other Study ID Numbers NN2211-3932
U1111-1119-8803 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date December 2018