Korean Post-marketing Surveillance for Onglyza®

This study is currently recruiting participants.
Verified July 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01575483
First received: April 10, 2012
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Onglyza® so that the regulatory authority can manage the marketing approval properly.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: No Intervention (subjects were previously treated with Onglyza®)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Korean Post-marketing Surveillance for Onglyza®

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adverse events occurrence [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Adverse Events and Serious Adverse Events [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
  • Effectiveness of Onglyza® measured by Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and 2-hr post-prandial glucose (2-hr PPG) comparing baseline data [ Time Frame: Baseline (Week 0), 12 weeks and 24 weeks of registration ] [ Designated as safety issue: No ]

Estimated Enrollment: 3900
Study Start Date: March 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with T2DM
Patients with diagnosis of type 2 diabetes mellitus (T2DM) initiating Onglyza® treatment within the approved indications will be enrolled
Drug: No Intervention (subjects were previously treated with Onglyza®)
No Intervention
Other Name: saxagliptin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with diagnosis of type 2 diabetes mellitus initiating Onglyza® treatment within the approved indications will be enrolled

Criteria

Inclusion Criteria:

  • Female and male patients who are at least 18 years of age
  • Patients with diagnosis of T2DM initiating Onglyza® treatment within the approved indications in Korea

Exclusion Criteria:

  • Indication which is not approved for Onglyza® in Korea
  • Patients with contraindication for the use of Onglyza® (as clarified in Korean label)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575483

Contacts
Contact: For Site information please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Locations
Korea, Republic of
Local Institution Not yet recruiting
Chuncheon-si, Gangwon-do, Korea, Republic of, 200-100
Contact: , Site 002         
Local Institution Not yet recruiting
Chuncheon-si, Gangwon-do, Korea, Republic of, 200-100
Contact: , Site 003         
Local Institution Not yet recruiting
Bucheon-si, Gyeonggi-do, Korea, Republic of, 421-819
Contact: , Site 008         
Local Institution Not yet recruiting
Bucheon-si, Gyeonggi-do, Korea, Republic of, 421-820
Contact: , Site 009         
Local Institution Not yet recruiting
Pusan, Korea, Republic of, 617-835
Contact: , Site 006         
Local Institution Not yet recruiting
Pusan, Korea, Republic of, 617-836
Contact: , Site 007         
Local Institution Recruiting
Seoul, Korea, Republic of, 138-240
Contact: , Site 001         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 138-842
Contact: , Site 004         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 138-821
Contact: , Site 005         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 156-860
Contact: , Site 010         
Local Institution Recruiting
Seoul, Korea, Republic of, 151-830
Contact: , Site 011         
Local Institution Recruiting
Seoul, Korea, Republic of, 151-015
Contact: , Site 012         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01575483     History of Changes
Other Study ID Numbers: CV181-171
Study First Received: April 10, 2012
Last Updated: July 17, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014