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Korean Post-marketing Surveillance for Kombiglyze XR®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754142
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date December 18, 2012
First Posted Date December 21, 2012
Last Update Posted Date August 8, 2017
Actual Study Start Date November 24, 2012
Actual Primary Completion Date September 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2012)
  • 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) ]
  • 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) ]
  • 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 ]
  • 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) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 3, 2013)
  • 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)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures
 (submitted: December 18, 2012)
  • Safety information related to factors (eg, gender, demographics etc) that may affect the safety of the drug [ Time Frame: Approximately up to 4.5 years ]
  • Safety information related to factors (eg, gender, demographics etc) that may affect the effectiveness of the drug [ Time Frame: Approximately up to 4.5 years ]
  • Safety information related to overdose, drug-to-drug interaction and laboratory abnormalities [ Time Frame: Approximately up to 4.5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Korean Post-marketing Surveillance for Kombiglyze XR®
Official Title Kombiglyze XR (Saxagliptin + Metformin XR Fixed Dose Combination) Regulatory Postmarketing Surveillance
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Diabetes Mellitus, Type 2
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 21, 2016)
755
Original Estimated Enrollment
 (submitted: December 18, 2012)
900
Actual Study Completion Date September 1, 2016
Actual Primary Completion Date September 1, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01754142
Other Study ID Numbers CV181-306
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account AstraZeneca
Verification Date August 2017