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 July 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01940770
First received: September 9, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


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 Bydureon Subcutaneous Injection 2 mg

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: 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.


Estimated Enrollment: 1100
Study Start Date: October 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Detailed Description:

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)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  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: NCT01940770

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

  Show 51 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD Quality & Safety Compliance Office
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01940770     History of Changes
Other Study ID Numbers: D5551C00001
Study First Received: September 9, 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)
Bydureon
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

ClinicalTrials.gov processed this record on July 22, 2014