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

AstraZeneca

Status: Completed

Conditions: Type 2 Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT01940770

EUPAS18608 (Registry Identifier)

D5551C00001

Details and patient eligibility

About

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

Full 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)

Enrollment: 1,137 patients

Sex: All

Volunteers: No Healthy Volunteers

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.