Study identification

PURI

https://redirect.ema.europa.eu/resource/37369

EU PAS number

EUPAS19606

Study ID

37369

Official title and acronym

Exenatide (Byetta subcutaneous injection) Specific Clinical Experience Investigation for long-term use (PMS Byetta Long Term Use SCEI)

DARWIN EU® study

No

Study countries

Japan

Study description

To confirm the safety and efficacy of Byetta subcutaneous injection (hereinafter referred to as Byetta) in long-term use under actual drug use. 1.Primary Objective To confirm development of adverse events with administration of Byetta. Especially, development of acute pancreatitis and cardiovascular related events (MACE:Major Adverse Cardiovascular Events) should be focused on.2.Secondary objective As the secondary objective of this investigation, the following items are to be investigated.- The safety and efficacy in patients with renal impairment - ADR development related to hypoglycaemia, digestive symptoms, and malignant neoplasm- Variation of HbA1c from the baseline- Changes of weight, blood pressure, and blood lipid- Change of satisfaction level with diabetes treatment- Expression of exenatide antibody in cases of hypersensitivity

Study status

Finalised
Research institutions and networks

Institutions

AstraZeneca
First published:
01/02/2024
Institution
Multiple centres: 616 centres are involved in the study

Contact details

Nakamura Kenji

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astrazeneca K.K.
Study protocol
Initial protocol

D5550C00001_EUPAS19606_Protocol_ENCePP

English (114.99 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only