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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01817569
Recruitment Status : Active, not recruiting
First Posted : March 25, 2013
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):

March 21, 2013
March 25, 2013
November 24, 2017
February 1, 2011
April 30, 2020   (Final data collection date for primary outcome measure)
Adverse event incidence. [ Time Frame: 3 years ]
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 ]
    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 ]
    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 ]
  • Mean change in blood pressure. [ Time Frame: 3 years. ]
  • Mean change in lipid metabolism. [ Time Frame: 3 years ]
    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.
 
Active, not recruiting
3100
April 30, 2020
April 30, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01817569
D5550C00001
EUPAS19606 ( Registry Identifier: ENCePP )
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
AstraZeneca
November 2017