Specific Clinical Experience Investigation for long-term use of Bydureon subcutaneous injection 2 mg and Bydureon SC Pen 2 mg (PMS Bydureon Long Term Use SCEI)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37460
• EU PAS number:
  EUPAS18608
• Study ID:
  37460
• Official title and acronym:
  Specific Clinical Experience Investigation for long-term use of Bydureon subcutaneous injection 2 mg and Bydureon SC Pen 2 mg (PMS Bydureon Long Term Use SCEI)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study 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 impairmentChanges of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, HbA1c, and blood lipidsBydureon 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 status:
  Finalised

Research institutions and networks

Institutions

AstraZeneca

Multiple centres: 366 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 13/02/2013

Actual: 13/02/2013

Study start date

Planned: 01/10/2013

Actual: 18/10/2013

Data analysis start date

Planned: 01/06/2020

Actual: 02/12/2019

Date of final study report

Planned: 31/08/2020

Actual: 01/07/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astrazeneca K.K.

Study protocol

Initial protocol

D5551C00001_BD_11-Dec-2014_ProtocolRedacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

D5551C00001