Skip to main content
OpenTrials
Completed

NCT Number: NCT01754142

Korean Post-marketing Surveillance for Kombiglyze XR®

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Kombiglyze XR (Saxagliptin + Metformin XR Fixed Dose Combination) Regulatory Postmarketing Surveillance

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2012
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.