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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01817569
First received: March 21, 2013
Last updated: August 11, 2014
Last verified: August 2014

March 21, 2013
August 11, 2014
February 2011
August 2018   (final data collection date for primary outcome measure)
Adverse event incidence. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Number of Adverse Drug Reactions
Same as current
Complete list of historical versions of study NCT01817569 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)
Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Type 2 Diabetes
Not Provided
Byetta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3100
August 2018
August 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Both
Not Provided
No
Contact: Maki Inoue M.Inoue@astrazeneca.com
Japan
 
NCT01817569
D5550C00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
AstraZeneca
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP