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

Study summary

No information provided.

Study identification

• 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

Multiple centres: 616 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:13/12/2010

Actual:13/12/2010

Study start date

Planned:01/02/2011

Actual:04/02/2011

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.

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

D5550C00001