Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01940770
First received: September 9, 2013
Last updated: September 11, 2014
Last verified: September 2014

September 9, 2013
September 11, 2014
October 2013
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 NCT01940770 on ClinicalTrials.gov Archive Site
  • Mean change of HbA1c [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of HbA1c from baseline as mean.
  • Mean change of weight [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of weight from baseline as mean.
  • Mean change of blood pressure [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of blood pressure from baseline as mean.
  • Mean change of lipid metabolism [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of lipid metabolism from baseline as mean.
  • Mean change of HbA1c [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of HbA1c from baseline as median.
  • Mean change of HbA1c [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of HbA1c from baseline as minimum.
  • Mean change of HbA1c [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of HbA1c from baseline as max.
  • Mean change of weight [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of weight from baseline as median.
  • Mean change of weight [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of weight from baseline as minimum.
  • Mean change of weight [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of weight from baseline as max.
  • Mean change of blood pressure [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of blood pressure from baseline as median.
  • Mean change of blood pressure [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of blood pressure from baseline as minimum.
  • Mean change of blood pressure [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of blood pressure from baseline as max.
  • Mean change of lipid metabolism [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of lipid metabolism from baseline as median.
  • Mean change of lipid metabolism [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    Change value of lipid metabolism from baseline as minimum.
  • Mean change of lipid metabolism [ Time Frame: from baseline up to 3 years ] [ Designated as safety issue: No ]
    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 Subcutaneous Injection 2 mg
Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg

To confirm the safety and efficacy of Bydureon subcutaneous injection 2 mg (hereinafter referred to as 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 subcutaneous injection 2 mg (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.
 
Recruiting
1100
August 2018
August 2018   (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.
Both
Not Provided
No
Contact: Maki Inoue M.Inoue@astrazeneca.com
Japan
 
NCT01940770
D5551C00001
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Shigeru Yoshida, MD Quality & Safety Compliance Office
AstraZeneca
September 2014

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