Clinical trial NCT01940770: Specific Clinical Experience Investigation for Long-term Use of Bydureon.
Official title: Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg and Bydureon Subcutaneous Injection 2 mg PEN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus(DM)
Bydureon
Exenatide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 1137
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.

Detailed 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 impairment
   * Changes of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, HbA1c, and blood lipids
   * Bydureon 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)

Eligibility criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adverse event incidence
timeFrame: 3 years
Secondary outcomes:
measure: Mean change of HbA1c
timeFrame: from baseline up to 3 years
measure: Mean change of weight
timeFrame: from baseline up to 3 years
measure: Mean change of blood pressure
timeFrame: from baseline up to 3 years
measure: Mean change of lipid metabolism
timeFrame: from baseline up to 3 years
measure: Mean change of HbA1c
timeFrame: from baseline up to 3 years
measure: Mean change of HbA1c
timeFrame: from baseline up to 3 years
measure: Mean change of HbA1c
timeFrame: from baseline up to 3 years
measure: Mean change of weight
timeFrame: from baseline up to 3 years
measure: Mean change of weight
timeFrame: from baseline up to 3 years
measure: Mean change of weight
timeFrame: from baseline up to 3 years
measure: Mean change of blood pressure
timeFrame: from baseline up to 3 years
measure: Mean change of blood pressure
timeFrame: from baseline up to 3 years
measure: Mean change of blood pressure
timeFrame: from baseline up to 3 years
measure: Mean change of lipid metabolism
timeFrame: from baseline up to 3 years
measure: Mean change of lipid metabolism
timeFrame: from baseline up to 3 years
measure: Mean change of lipid metabolism
timeFrame: from baseline up to 3 years
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ishikawa
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
city: Yamanashi
country: Japan
facility: Research Site
Study officials:
affiliation: Quality & Safety Compliance Office
name: Shigeru Yoshida, MD
role: STUDY_DIRECTOR
References: