Korean Post-marketing Surveillance for Kombiglyze XR®

• ClinicalTrials.gov Identifier: NCT01754142
• Recruitment Status: Completed
• First Posted: December 21, 2012
• Last Update Posted: August 8, 2017
• Sponsor: AstraZeneca
• 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

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

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

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