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Specific Clinical Experience Investigation for Long-term Use of Bydureon

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01940770
First received: September 9, 2013
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
To confirm the safety and efficacy of 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 and Bydureon Subcutaneous Injection 2 mg PEN

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: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Detailed Description:

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)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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

Locations
Japan
Research Site
Aichi, Japan
Research Site
Akita, Japan
Research Site
Aomori, Japan
Research Site
Chiba, Japan
Research Site
Ehime, Japan
Research Site
Fukui, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Gifu, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyogo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Iwate, Japan
Research Site
Kagawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kochi, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Mie, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nagano, Japan
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Niigata, Japan
Research Site
Oita, Japan
Research Site
Okayama, Japan
Research Site
Okinawa, Japan
Research Site
Osaka, Japan
Research Site
Saga, Japan
Research Site
Saitama, Japan
Research Site
Shiga, Japan
Research Site
Shimane, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
Research Site
Tokushima, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Toyama, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Research Site
Yamanashi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD Quality & Safety Compliance Office
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01940770     History of Changes
Other Study ID Numbers: D5551C00001 
Study First Received: September 9, 2013
Last Updated: October 27, 2016
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:
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on December 08, 2016