Clinical trial NCT01817569: Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)
Official title: Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus (DM)
Byetta
Exenatide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-03-25
Enrollment: 2948
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: Patients are eligible to be included in the study if they meet all of the following criteria:

The patient who is diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.

The patient follows the PI of Byetta.

Brief summary: The purpose of this investigation is to describe general safety profile of type II Diabetes Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices

Detailed description: Specific Clinical Experience Investigation for long-term use of exenatide (Byetta subcutaneous injection).

Eligibility criteria: Inclusion Criteria:

- Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.

Primary outcomes:
measure: Adverse event incidence.
timeFrame: 3 years
Secondary outcomes:
measure: Mean change of HbA1c.
timeFrame: 3 years
measure: Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs).
timeFrame: 3 years
measure: Mean change in weight.
timeFrame: 3 years
measure: Mean change in blood pressure.
timeFrame: 3 years.
measure: Mean change in lipid metabolism.
timeFrame: 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: 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: AstraZeneca
name: Shigeru Yoshida, MD
role: STUDY_DIRECTOR
References: