We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Specific Clinical Experience Investigation for Long-term Use of Bydureon

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01940770
First Posted: September 12, 2013
Last Update Posted: August 25, 2017
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.
Information provided by (Responsible Party):
AstraZeneca
September 9, 2013
September 12, 2013
August 25, 2017
October 18, 2013
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 NCT01940770 on ClinicalTrials.gov Archive Site
  • Mean change of HbA1c [ Time Frame: from baseline up to 3 years ]
    Change value of HbA1c from baseline as mean.
  • Mean change of weight [ Time Frame: from baseline up to 3 years ]
    Change value of weight from baseline as mean.
  • Mean change of blood pressure [ Time Frame: from baseline up to 3 years ]
    Change value of blood pressure from baseline as mean.
  • Mean change of lipid metabolism [ Time Frame: from baseline up to 3 years ]
    Change value of lipid metabolism from baseline as mean.
  • Mean change of HbA1c [ Time Frame: from baseline up to 3 years ]
    Change value of HbA1c from baseline as median.
  • Mean change of HbA1c [ Time Frame: from baseline up to 3 years ]
    Change value of HbA1c from baseline as minimum.
  • Mean change of HbA1c [ Time Frame: from baseline up to 3 years ]
    Change value of HbA1c from baseline as max.
  • Mean change of weight [ Time Frame: from baseline up to 3 years ]
    Change value of weight from baseline as median.
  • Mean change of weight [ Time Frame: from baseline up to 3 years ]
    Change value of weight from baseline as minimum.
  • Mean change of weight [ Time Frame: from baseline up to 3 years ]
    Change value of weight from baseline as max.
  • Mean change of blood pressure [ Time Frame: from baseline up to 3 years ]
    Change value of blood pressure from baseline as median.
  • Mean change of blood pressure [ Time Frame: from baseline up to 3 years ]
    Change value of blood pressure from baseline as minimum.
  • Mean change of blood pressure [ Time Frame: from baseline up to 3 years ]
    Change value of blood pressure from baseline as max.
  • Mean change of lipid metabolism [ Time Frame: from baseline up to 3 years ]
    Change value of lipid metabolism from baseline as median.
  • Mean change of lipid metabolism [ Time Frame: from baseline up to 3 years ]
    Change value of lipid metabolism from baseline as minimum.
  • Mean change of lipid metabolism [ Time Frame: from baseline up to 3 years ]
    Change value of lipid metabolism from baseline as max.
Same as current
Not Provided
Not Provided
 
Specific Clinical Experience Investigation for Long-term Use of Bydureon
Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg and Bydureon Subcutaneous Injection 2 mg PEN
To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.

To confirm the safety and efficacy of Bydureon (hereinafter referred to as Bydureon) in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.

  1. Primary Objective To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Bydureon under daily practices.
  2. Secondary objective As the secondary objective of this S-CEI, the following items are to be investigated.

    • Frequencies of AEs related to cardiovascular events, hypoglycaemia, digestive symptoms, and injection site reaction.
    • Development of pancreatitis, renal impairment (especially acute renal failure), hypersensitivity reaction, and malignant tumour (especially thyroid tumour and pancreatic malignancy)
    • Safety in patients with mild or moderate renal impairment
    • Changes of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, HbA1c, and blood lipids
    • Bydureon administration under daily practices focusing on the patient's demographics and clinical characteristics of diabetes mellitus (duration of diabetes mellitus, treatment duration, complications, Bydureon administration, etc)
    • Anti-exenatide antibody titer in AE cases (hypersensitivity, loss of control of blood sugar)
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The patients with type 2 diabetes mellitus who will be given Bydureon for the first time and who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.
Type 2 Diabetes
Not Provided
Not Provided
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
1137
April 30, 2020
April 30, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

- The patients with type 2 diabetes mellitus who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.

Exclusion Criteria:

  • No past history of hypersensitivity to the components of Bydureon.
  • Not the patient with diabetic ketoacidosis, diabetic coma/ precoma, and/ or type 1 diabetes mellitus.
  • Bydureon will not be administered to the patient in an emergency situation such as severe infection and operation.
  • Not the patient with severe renal impairment, including those receiving dialysis.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01940770
D5551C00001
EUPAS18608 ( Registry Identifier: ENCePP )
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Shigeru Yoshida, MD Quality & Safety Compliance Office
AstraZeneca
August 2017