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

NCT02090673 | Completed

• 1 other identifier: MB001-078
• Study Type: observational
• Target: 1,711
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

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

  At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks

Secondary Outcomes (4)

• Change from baseline to endpoint in Hemoglobin A1c (HbA1c)

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

• Change from baseline to endpoint in Body weight

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

• Change from baseline to endpoint in Fasting plasma glucose

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

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

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

Study Arms (1)

Group1:Type 2 diabetic patients treated with Exenatide therapy

Korean patients who are at least 18 years old, diagnosed with type 2 diabetes, and are treated with Exenatide in an ambulatory care setting according to the approved label

Drug: Exenatide

Interventions

Exenatide DRUG

Group1:Type 2 diabetic patients treated with Exenatide therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic, hospital and teaching hospitals

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Local Institution

Seoul, 110-756, South Korea

Location

Related Publications (1)

• Hwang YC, Kim A, Jo E, Yang Y, Cho JH, Lee BW. Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice. BMC Endocr Disord. 2017 Oct 25;17(1):68. doi: 10.1186/s12902-017-0220-4.

  PMID: 29065865 DERIVED

Related Links

• Investigator Inquiry form
• CSR\_Synopsis\_MB001-078.pdf

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

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: March 17, 2014
• First Posted: March 18, 2014
• Study Start: February 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

KR (1)