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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  To confirm the efficacy of Byetta in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series, Clinical Experience Investigation based on Japanese regulation

Study drug and medical condition

• Name of medicine:
  BYETTA

Population studied

• Short description of the study population:
  Type II diabetes mellitus patients
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  2950

Study design details

• Main study objective:
  To confirm the safety and efficacy of Byetta in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.
• Outcomes:
  To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Byetta under daily practices. Frequencies of AEs related to cardiovascular events, hypoglycaemia, digestive symptoms, and injection site reaction, 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.
• Data analysis plan:
  risk estimation, measures of risk

Documents

Study results

D5550C00001_redacted_CSR_synopsis