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Korean Post-marketing Surveillance for Onglyza®

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ClinicalTrials.gov Identifier: NCT01575483
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: No Intervention (subjects were previously treated with Onglyza®)

Study Type : Observational
Actual Enrollment : 3433 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Korean Post-marketing Surveillance for Onglyza®
Actual Study Start Date : March 1, 2012
Actual Primary Completion Date : September 7, 2016
Actual Study Completion Date : September 7, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Adverse events occurrence [ Time Frame: 30 days after last dose of study drug ]

Secondary Outcome Measures :
  1. Number of Adverse Events and Serious Adverse Events [ Time Frame: 30 days after last dose of study drug ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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): NCT01575483


Locations
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01575483     History of Changes
Other Study ID Numbers: CV181-171
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents