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Completed

NCT Number: NCT01940770

Specific Clinical Experience Investigation for Long-term Use of Bydureon.

To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.

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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

To confirm the safety and efficacy of Bydureon (hereinafter referred to as Bydureon) in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.

  • Primary Objective To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Bydureon under daily practices.
  • Secondary objective As the secondary objective of this S-CEI, the following items are to be investigated.
  • Frequencies of AEs related to cardiovascular events, hypoglycaemia, digestive symptoms, and injection site reaction.
  • Development of pancreatitis, renal impairment (especially acute renal failure), hypersensitivity reaction, and malignant tumour (especially thyroid tumour and pancreatic malignancy)
  • Safety in patients with mild or moderate renal impairment
  • Changes of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, HbA1c, and blood lipids
  • Bydureon administration under daily practices focusing on the patient's demographics and clinical characteristics of diabetes mellitus (duration of diabetes mellitus, treatment duration, complications, Bydureon administration, etc)
  • Anti-exenatide antibody titer in AE cases (hypersensitivity, loss of control of blood sugar)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patients with type 2 diabetes mellitus who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.

Exclusion criteria

  • No past history of hypersensitivity to the components of Bydureon.
  • Not the patient with diabetic ketoacidosis, diabetic coma/ precoma, and/ or type 1 diabetes mellitus.
  • Bydureon will not be administered to the patient in an emergency situation such as severe infection and operation.
  • Not the patient with severe renal impairment, including those receiving dialysis.

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: from baseline up to 3 years

    Change value of HbA1c from baseline as mean.

  2. Mean change of weight

    Time frame: from baseline up to 3 years

    Change value of weight from baseline as mean.

  3. Mean change of blood pressure

    Time frame: from baseline up to 3 years

    Change value of blood pressure from baseline as mean.

  4. Mean change of lipid metabolism

    Time frame: from baseline up to 3 years

    Change value of lipid metabolism from baseline as mean.

  5. Mean change of HbA1c

    Time frame: from baseline up to 3 years

    Change value of HbA1c from baseline as median.

  6. Mean change of HbA1c

    Time frame: from baseline up to 3 years

    Change value of HbA1c from baseline as minimum.

  7. Mean change of HbA1c

    Time frame: from baseline up to 3 years

    Change value of HbA1c from baseline as max.

  8. Mean change of weight

    Time frame: from baseline up to 3 years

    Change value of weight from baseline as median.

  9. Mean change of weight

    Time frame: from baseline up to 3 years

    Change value of weight from baseline as minimum.

  10. Mean change of weight

    Time frame: from baseline up to 3 years

    Change value of weight from baseline as max.

  11. Mean change of blood pressure

    Time frame: from baseline up to 3 years

    Change value of blood pressure from baseline as median.

  12. Mean change of blood pressure

    Time frame: from baseline up to 3 years

    Change value of blood pressure from baseline as minimum.

  13. Mean change of blood pressure

    Time frame: from baseline up to 3 years

    Change value of blood pressure from baseline as max.

  14. Mean change of lipid metabolism

    Time frame: from baseline up to 3 years

    Change value of lipid metabolism from baseline as median.

  15. Mean change of lipid metabolism

    Time frame: from baseline up to 3 years

    Change value of lipid metabolism from baseline as minimum.

  16. Mean change of lipid metabolism

    Time frame: from baseline up to 3 years

    Change value of lipid metabolism from baseline as max.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg and Bydureon Subcutaneous Injection 2 mg PEN

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 12, 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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