Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Korean Post-marketing Surveillance for Kombiglyze XR®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01754142
First received: December 18, 2012
Last updated: September 21, 2016
Last verified: September 2016
  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 Kombiglyze Extended release (XR) so that the regulatory authority can manage the marketing approval properly

Condition
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Kombiglyze XR (Saxagliptin + Metformin XR Fixed Dose Combination) Regulatory Postmarketing Surveillance

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Adverse events (AEs)

  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 755
Study Start Date: November 2012
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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
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: 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 
Study First Received: December 18, 2012
Last Updated: September 21, 2016
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

ClinicalTrials.gov processed this record on September 26, 2016