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Completed

NCT Number: NCT01817569

Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

The purpose of this investigation is to describe general safety profile of type II Diabetes Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

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About this study

Specific Clinical Experience Investigation for long-term use of exenatide (Byetta subcutaneous injection).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.

Treatment and study plan

Primary outcomes

  1. Adverse event incidence.

    Time frame: 3 years

    Number of Adverse Drug Reactions

Secondary outcomes

  1. Mean change of HbA1c.

    Time frame: 3 years

    Change value of HbA1c from baseline as mean / median / minimum / max.

  2. Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs).

    Time frame: 3 years

    The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia. Each of the 8 items are scored on a scale of 0-6 where 0= very dissatisfied and 6= very satisfied. The higher score, the greater satisfaction with the treatment.

  3. Mean change in weight.

    Time frame: 3 years

  4. Mean change in blood pressure.

    Time frame: 3 years.

  5. Mean change in lipid metabolism.

    Time frame: 3 years

    Change value of lipid metabolism from baseline as mean / median / minimum / max.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2013
Registry last updated
Jul 20, 2020

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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