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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01817569
First received: March 21, 2013
Last updated: July 10, 2014
Last verified: July 2014
  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: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Detailed Description:

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

  Eligibility

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

Contacts
Contact: Maki Inoue M.Inoue@astrazeneca.com

  Show 125 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01817569     History of Changes
Other Study ID Numbers: D5550C00001
Study First Received: March 21, 2013
Last Updated: July 10, 2014
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 31, 2014