Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

NCT ID: NCT02288273

Last Updated: 2017-01-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

Detailed Description

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A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bydureon

Once weekly injected exenatide

Group Type EXPERIMENTAL

Bydureon

Intervention Type DRUG

Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.

Placebo

Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Bydureon

Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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exenatide

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin \> or = to 1500mg/day as monotherapy for at least 8 weeks
* Hemoglobin A1c (HbA1c) 7% to 10% at screening
* Body mass index (BMI) \< or = to 45 kg/m2

Exclusion Criteria

* History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening
* History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening
* History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
* History of prescription or over the counter weight loss medication during 3 months prior to screening
* Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Anaheim, California, United States

Site Status

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Chino, California, United States

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Los Angeles, California, United States

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North Hollywood, California, United States

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Santa Ana, California, United States

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Spring Valley, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Port Orange, Florida, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Edina, Minnesota, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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Las Vegas, Nevada, United States

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Franklin, Ohio, United States

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Marion, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Mt. Pleasant, South Carolina, United States

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Rapid City, South Dakota, United States

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Corpus Christi, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Salt Lake City, Utah, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Olympia, Washington, United States

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Countries

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United States

Other Identifiers

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D5551L00006

Identifier Type: -

Identifier Source: org_study_id

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