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Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01817569
First received: March 21, 2013
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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.

Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse event incidence. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Number of Adverse Drug Reactions


Secondary Outcome Measures:
  • Mean change of HbA1c. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Change value of HbA1c from baseline as mean / median / minimum / max.

  • Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia. Each of the 8 items are scored on a scale of 0-6 where 0= very dissatisfied and 6= very satisfied. The higher score, the greater satisfaction with the treatment.

  • Mean change in weight. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Mean change in blood pressure. [ Time Frame: 3 years. ] [ Designated as safety issue: No ]
  • Mean change in lipid metabolism. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Change value of lipid metabolism from baseline as mean / median / minimum / max.


Estimated Enrollment: 3100
Study Start Date: February 2011
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817569

Locations
Japan
Research Site
Aichi, Japan
Research Site
Akita, Japan
Research Site
Aomori, Japan
Research Site
Chiba, Japan
Research Site
Ehime, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Gifu, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyogo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Iwate, Japan
Research Site
Kagawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kochi, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Mie, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nagano, Japan
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Niigata, Japan
Research Site
Oita, Japan
Research Site
Okayama, Japan
Research Site
Okinawa, Japan
Research Site
Osaka, Japan
Research Site
Saga, Japan
Research Site
Saitama, Japan
Research Site
Shiga, Japan
Research Site
Shimane, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
Research Site
Tokushima, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Toyama, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Research Site
Yamanashi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01817569     History of Changes
Other Study ID Numbers: D5550C00001 
Study First Received: March 21, 2013
Last Updated: September 13, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Diabetes Mellitus (DM)
Byetta
Exenatide

Additional relevant MeSH terms:
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 26, 2016