NCT01940770

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,137

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

47 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 18, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

6.1 years

First QC Date

September 9, 2013

Last Update Submit

July 17, 2020

Conditions

Type 2 Diabetes

Keywords

Diabetes Mellitus(DM)BydureonExenatide

Outcome Measures

Primary Outcomes (1)

  • Adverse event incidence

    Number of Adverse Drug Reactions

    3 years

Secondary Outcomes (16)

  • Mean change of HbA1c

    from baseline up to 3 years

  • Mean change of weight

    from baseline up to 3 years

  • Mean change of blood pressure

    from baseline up to 3 years

  • Mean change of lipid metabolism

    from baseline up to 3 years

  • Mean change of HbA1c

    from baseline up to 3 years

  • +11 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Research Site

Aichi, D5551C00001, Japan

Location

Research Site

Akita, D5551C00001, Japan

Location

Research Site

Aomori, D5551C00001, Japan

Location

Research Site

Chiba, D5551C00001, Japan

Location

Research Site

Ehime, D5551C00001, Japan

Location

Research Site

Fukui, D5551C00001, Japan

Location

Research Site

Fukuoka, D5551C00001, Japan

Location

Research Site

Fukushima, D5551C00001, Japan

Location

Research Site

Gifu, D5551C00001, Japan

Location

Research Site

Gunma, D5551C00001, Japan

Location

Research Site

Hiroshima, D5551C00001, Japan

Location

Research Site

Hokkaido, D5551C00001, Japan

Location

Research Site

Hyōgo, D5551C00001, Japan

Location

Research Site

Ibaraki, D5551C00001, Japan

Location

Research Site

Ishikawa, D5551C00001, Japan

Location

Research Site

Kagawa, D5551C00001, Japan

Location

Research Site

Kagoshima, D5551C00001, Japan

Location

Research Site

Kanagawa, D5551C00001, Japan

Location

Research Site

Kochi, D5551C00001, Japan

Location

Research Site

Kumamoto, D5551C00001, Japan

Location

Research Site

Kyoto, D5551C00001, Japan

Location

Research Site

Mie, D5551C00001, Japan

Location

Research Site

Miyagi, D5551C00001, Japan

Location

Research Site

Miyazaki, D5551C00001, Japan

Location

Research Site

Nagano, D5551C00001, Japan

Location

Research Site

Nagasaki, D5551C00001, Japan

Location

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Nara, D5551C00001, Japan

Location

Research Site

Niigata, D5551C00001, Japan

Location

Research Site

Numakunai, D5551C00001, Japan

Location

Research Site

Okayama, D5551C00001, Japan

Location

Research Site

Okinawa, D5551C00001, Japan

Location

Research Site

Osaka, D5551C00001, Japan

Location

Research Site

Ōita, D5551C00001, Japan

Location

Research Site

Saga, D5551C00001, Japan

Location

Research Site

Saitama, D5551C00001, Japan

Location

Research Site

Shiga, D5551C00001, Japan

Location

Research Site

Shimane, D5551C00001, Japan

Location

Research Site

Shizuoka, D5551C00001, Japan

Location

Research Site

Tochigi, D5551C00001, Japan

Location

Research Site

Tokushima, D5551C00001, Japan

Location

Research Site

Tokyo, D5551C00001, Japan

Location

Research Site

Tottori, D5551C00001, Japan

Location

Research Site

Toyama, D5551C00001, Japan

Location

Research Site

Wakayama, D5551C00001, Japan

Location

Research Site

Yamagata, D5551C00001, Japan

Location

Research Site

Yamaguchi, D5551C00001, Japan

Location

Research Site

Yamanashi, D5551C00001, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shigeru Yoshida, MD

    Quality & Safety Compliance Office

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 12, 2013

Study Start

October 18, 2013

Primary Completion

November 29, 2019

Study Completion

November 29, 2019

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

JP(47)