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

Status Completed

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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Type 2 Diabetes

• NCT number: NCT01940770
• Study type: Observational
• Source: AstraZeneca
• Status: Completed
• Start date: October 18, 2013
• Completion date: November 29, 2019