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

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT01940770
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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.

1. Primary Objective To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Bydureon under daily practices.

2. 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)

Study Timeline

• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-12
• Study Start: 2013-10-18
• Primary Completion: 2019-11-29
• Study Completion: 2019-11-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1137

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event incidence	3 years	Number of Adverse Drug Reactions

Secondary Outcome Measures

Name	Time	Method
Mean change of HbA1c	from baseline up to 3 years	Change value of HbA1c from baseline as max.
Mean change of weight	from baseline up to 3 years	Change value of weight from baseline as max.
Mean change of blood pressure	from baseline up to 3 years	Change value of blood pressure from baseline as max.
Mean change of lipid metabolism	from baseline up to 3 years	Change value of lipid metabolism from baseline as max.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan