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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940770
• Other study ID #: D5551C00001
• Secondary ID: EUPAS18608
• Status: Completed
• Start date: October 18, 2013
• Est. completion date: November 29, 2019

Study information

• Verified date: July 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1137
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Locations

Country	Name	City	State
Japan	Research Site	Aichi
Japan	Research Site	Akita
Japan	Research Site	Aomori
Japan	Research Site	Chiba
Japan	Research Site	Ehime
Japan	Research Site	Fukui
Japan	Research Site	Fukuoka
Japan	Research Site	Fukushima
Japan	Research Site	Gifu
Japan	Research Site	Gunma
Japan	Research Site	Hiroshima
Japan	Research Site	Hokkaido
Japan	Research Site	Hyogo
Japan	Research Site	Ibaraki
Japan	Research Site	Ishikawa
Japan	Research Site	Iwate
Japan	Research Site	Kagawa
Japan	Research Site	Kagoshima
Japan	Research Site	Kanagawa
Japan	Research Site	Kochi
Japan	Research Site	Kumamoto
Japan	Research Site	Kyoto
Japan	Research Site	Mie
Japan	Research Site	Miyagi
Japan	Research Site	Miyazaki
Japan	Research Site	Nagano
Japan	Research Site	Nagasaki
Japan	Research Site	Nara
Japan	Research Site	Niigata
Japan	Research Site	Oita
Japan	Research Site	Okayama
Japan	Research Site	Okinawa
Japan	Research Site	Osaka
Japan	Research Site	Saga
Japan	Research Site	Saitama
Japan	Research Site	Shiga
Japan	Research Site	Shimane
Japan	Research Site	Shizuoka
Japan	Research Site	Tochigi
Japan	Research Site	Tokushima
Japan	Research Site	Tokyo
Japan	Research Site	Tottori
Japan	Research Site	Toyama
Japan	Research Site	Wakayama
Japan	Research Site	Yamagata
Japan	Research Site	Yamaguchi
Japan	Research Site	Yamanashi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event incidence	Number of Adverse Drug Reactions	3 years
Secondary	Mean change of HbA1c	Change value of HbA1c from baseline as mean.	from baseline up to 3 years
Secondary	Mean change of weight	Change value of weight from baseline as mean.	from baseline up to 3 years
Secondary	Mean change of blood pressure	Change value of blood pressure from baseline as mean.	from baseline up to 3 years
Secondary	Mean change of lipid metabolism	Change value of lipid metabolism from baseline as mean.	from baseline up to 3 years
Secondary	Mean change of HbA1c	Change value of HbA1c from baseline as median.	from baseline up to 3 years
Secondary	Mean change of HbA1c	Change value of HbA1c from baseline as minimum.	from baseline up to 3 years
Secondary	Mean change of HbA1c	Change value of HbA1c from baseline as max.	from baseline up to 3 years
Secondary	Mean change of weight	Change value of weight from baseline as median.	from baseline up to 3 years
Secondary	Mean change of weight	Change value of weight from baseline as minimum.	from baseline up to 3 years
Secondary	Mean change of weight	Change value of weight from baseline as max.	from baseline up to 3 years
Secondary	Mean change of blood pressure	Change value of blood pressure from baseline as median.	from baseline up to 3 years
Secondary	Mean change of blood pressure	Change value of blood pressure from baseline as minimum.	from baseline up to 3 years
Secondary	Mean change of blood pressure	Change value of blood pressure from baseline as max.	from baseline up to 3 years
Secondary	Mean change of lipid metabolism	Change value of lipid metabolism from baseline as median.	from baseline up to 3 years
Secondary	Mean change of lipid metabolism	Change value of lipid metabolism from baseline as minimum.	from baseline up to 3 years
Secondary	Mean change of lipid metabolism	Change value of lipid metabolism from baseline as max.	from baseline up to 3 years

External Links

•   CSR Synopsis