NCT01754142

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
755

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

3.8 years

First QC Date

December 18, 2012

Last Update Submit

August 7, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

  • Occurrence of known and unexpected adverse events, especially serious adverse events

    30 days after last dose of study drug (Approximately up to 4.5 years)

  • Incidence of adverse events under the routine drug use

    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)

    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)

    Baseline and Week 24 (for patients that have a post Week 12 follow-up visit)

Secondary Outcomes (3)

  • Safety information related to factors (eg, gender, demographics etc) that may affect the safety of the drug based on incidence rates of AEs

    Approximately up to 4.5 years

  • Safety information related to factors (eg, gender, demographics etc) that may affect the effectiveness of the drug based on incidence rates of AEs

    Approximately up to 4.5 years

  • Safety information related to overdose, drug-to-drug interaction and laboratory abnormalities based on incidence rates of AEs

    Approximately up to 4.5 years

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of type 2 diabetes mellitus initiating Kombiglyze XR treatment within the approved indications will be enrolled

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 21, 2012

Study Start

November 24, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

KR(1)