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OpenTrials
Completed

NCT Number: NCT02090673

Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 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

Local Institution

Seoul, 110-756, 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

  • Male or female at least 18 years of age
  • Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
  • Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information

Exclusion criteria

  • Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
  • Are pregnant or have intentions of becoming pregnant within the duration of the study
  • Contraindications

Treatment and study plan

exenatide

Drug

Primary outcomes

  1. The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus

    Time frame: At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks

Secondary outcomes

  1. Change from baseline to endpoint in Hemoglobin A1c (HbA1c)

    Time frame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks

  2. Change from baseline to endpoint in Body weight

    Time frame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks

  3. Change from baseline to endpoint in Fasting plasma glucose

    Time frame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks

  4. Change from baseline to endpoint in subjective measures include improvement of main indication

    Time frame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 18, 2014
Registry last updated
Aug 20, 2015

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.

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