Korean Post-marketing Surveillance for Onglyza®

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01575483
First received: April 10, 2012
Last updated: August 19, 2014
Last verified: August 2014
  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: May 2017
Estimated Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 19, 2014
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on September 14, 2014