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 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 efficacy of Bydureon (hereinafter referred to as Bydureon) 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:
  BYDUREON

Population studied

• Short description of the study population:
  The patients with type 2 diabetes mellitus who will be given Bydureon for the first time and who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.; The patients who meet the following conditions:; - The patients with type 2 diabetes mellitus who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.; The patient who will receive Bydureon in any of the following combinations:;  Bydureon + sulfonylurea;  Bydureon + biguanides;  Bydureon + thiazolidines;  Bydureon + sulfonylurea + biguanides;  Bydureon + sulfonylurea + thiazolidines;  Bydureon + biguanides + thiazolidines; - No past history of hypersensitivity to the components of Bydureon.; - Not the patient with diabetic ketoacidosis, diabetic coma/precoma, and/or type 1 diabetes mellitus.; - Bydureon will not be administered to the patient in an emergency situation such as severe infection and operation.; - Not the patient with severe renal impairment, including those receiving dialysis.
• 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

  Other

  Pregnant women

  Renal impaired
• Special population of interest, other:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  1100

Study design details

• Main study objective:
  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.
• Outcomes:
  To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Bydureon 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

D5551C00001_redacted_CSR_Synopsis