Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Sponsor AstraZeneca
Start date October 2013
End date April 2020
Trial size 1100 participants
Trial identifier NCT01940770, D5551C00001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Adverse event incidence
time frame: 3 years

Secondary Outcomes

Measure
Mean change of HbA1c
time frame: from baseline up to 3 years
Mean change of weight
time frame: from baseline up to 3 years
Mean change of blood pressure
time frame: from baseline up to 3 years
Mean change of lipid metabolism
time frame: from baseline up to 3 years
Mean change of HbA1c
time frame: from baseline up to 3 years
Mean change of HbA1c
time frame: from baseline up to 3 years
Mean change of HbA1c
time frame: from baseline up to 3 years
Mean change of weight
time frame: from baseline up to 3 years
Mean change of weight
time frame: from baseline up to 3 years
Mean change of weight
time frame: from baseline up to 3 years
Mean change of blood pressure
time frame: from baseline up to 3 years
Mean change of blood pressure
time frame: from baseline up to 3 years
Mean change of blood pressure
time frame: from baseline up to 3 years
Mean change of lipid metabolism
time frame: from baseline up to 3 years
Mean change of lipid metabolism
time frame: from baseline up to 3 years
Mean change of lipid metabolism
time frame: from baseline up to 3 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg and Bydureon Subcutaneous Injection 2 mg PEN
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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.