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Korean Post-marketing Surveillance for Kombiglyze XR®

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ClinicalTrials.gov Identifier: NCT01754142
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Kombiglyze Extended release (XR) so that the regulatory authority can manage the marketing approval properly

Condition or disease
Diabetes Mellitus, Type 2

Study Design

Study Type : Observational
Actual Enrollment : 755 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Kombiglyze XR (Saxagliptin + Metformin XR Fixed Dose Combination) Regulatory Postmarketing Surveillance
Actual Study Start Date : November 24, 2012
Primary Completion Date : September 1, 2016
Study Completion Date : September 1, 2016
Groups and Cohorts

Group/Cohort
Type 2 diabetes mellitus subjects initiating Kombiglyze XR
Patients with diagnosis of type 2 diabetes mellitus initiating Kombiglyze XR treatment within the approved indications will be enrolled


Outcome Measures

Primary Outcome Measures :
  1. Occurrence of known and unexpected adverse events, especially serious adverse events [ Time Frame: 30 days after last dose of study drug (Approximately up to 4.5 years) ]
  2. Incidence of adverse events under the routine drug use [ Time Frame: 30 days after last dose of study drug (Approximately up to 4.5 years) ]
  3. Effectiveness of Kombiglyze XR as assessed by change from baseline in Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hr PPG) [ Time Frame: Baseline and Week 12 ]
  4. Effectiveness of Kombiglyze XR as assessed by change from baseline in Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hr PPG) [ Time Frame: Baseline and Week 24 (for patients that have a post Week 12 follow-up visit) ]

Secondary Outcome Measures :
  1. Safety information related to factors (eg, gender, demographics etc) that may affect the safety of the drug based on incidence rates of AEs [ Time Frame: Approximately up to 4.5 years ]
    Adverse events (AEs)

  2. Safety information related to factors (eg, gender, demographics etc) that may affect the effectiveness of the drug based on incidence rates of AEs [ Time Frame: Approximately up to 4.5 years ]
  3. Safety information related to overdose, drug-to-drug interaction and laboratory abnormalities based on incidence rates of AEs [ Time Frame: Approximately up to 4.5 years ]

Eligibility Criteria

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 Kombiglyze XR treatment within the approved indications will be enrolled
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • ≥ 18 years of age
  • Have diagnosed Type 2 diabetes mellitus (T2DM)
  • Are initiating Kombiglyze XR treatment within the approved Korean indications

Exclusion Criteria:

  • Being treated for an indication not approved for the use of Kombiglyze XR in Korea
  • Is contraindicated for the use of Kombiglyze XR as described in the Korean label
Contacts and Locations

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): NCT01754142


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01754142     History of Changes
Other Study ID Numbers: CV181-306
First Posted: December 21, 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