Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:16 - Any
Updated:4/21/2016
Start Date:April 2006
End Date:August 2014

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A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications

A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of
Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with
Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral
Antidiabetic Medications.

This trial is designed to examine the effect of exenatide once weekly compared to exenatide
twice daily on glucose control and safety in subjects for at least 30 weeks. The study is
also designed to examine glucose control during the transition from exenatide twice daily
for 30 weeks to exenatide once weekly. Long-term safety and efficacy will be monitored
during the open-ended assessment periods. This study will be conducted in approximately 300
subjects with type 2 diabetes treated with diet modification and exercise alone or in
combination with a stable regimen of metformin, SU, thiazolidinedione (TZD), a combination
of metformin and SU, a combination of metformin and TZD, or a combination of SU and TZD.

Inclusion Criteria:

- Has type 2 diabetes mellitus treated with diet modification and exercise alone or in
combination with a stable regimen of a combination of metformin, sulphonylureas, and
thiazolidinediones for a minimum of 2 months at screening.

- Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.

- Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.

- (For sub-study) Currently participating in open ended assessment period of main study
2993 LAR105

Exclusion Criteria:

- Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any
glucagon-like peptide-1 (GLP-1) analog.

- Received any investigational drug or has participated in any type of clinical trial
within 30 days prior to screening.

- Has been treated, is currently treated, or is expected to require or undergo
treatment with any of the following excluded medications:

- Alpha glucosidase inhibitor or meglitinide within 30 days of screening;

- Insulin within 2 weeks prior to screening or insulin for longer than 1 week
within 3 months of screening;

- Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;

- Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or
intramuscular route; or potent, inhaled, or intrapulmonary steroids known to
have a high rate of systemic absorption;

- Regular use (> 14 days) of medications with addictive potential such as opiates
and opioids;

- Prescription or over-the-counter weight loss medications within 6 months of
screening.

- (For sub-study) Subjects will be terminated from study who do not participate in the
dual chamber pen substudy
We found this trial at
25
sites
Winston-Salem, North Carolina 27103
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Butte, Montana 59701
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Butte, MT
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Chicago, IL
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Cincinnati, Ohio 45219
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Cincinnati, OH
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Dallas, Texas 75230
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Dallas, TX
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Detroit, Michigan 48202
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Detroit, MI
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Durham, North Carolina 27713
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Durham, NC
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Encino, California 91436
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Encino, CA
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Greer, South Carolina 29651
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Greer, SC
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Indianapolis, Indiana 46254
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Indianapolis, IN
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La Jolla, California 92037
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La Jolla, CA
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Lexington, Kentucky 40503
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Lexington, KY
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Marion, Ohio 43302
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Marion, OH
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Miami, Florida 33156
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Miami, FL
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Minneapolis, Minnesota 55416
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Minneapolis, MN
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Olympia, Washington 98502
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Olympia, WA
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Philadelphia, Pennsylvania 19146
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Philadelphia, PA
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Portland, Oregon 97239
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Portland, OR
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Rochester, New York 14609
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Rochester, NY
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San Antonio, Texas 78229
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San Antonio, TX
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San Diego, California 92161
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San Diego, CA
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St. Louis, Missouri 63141
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St. Louis, MO
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Toronto,
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Walnut Creek, California 94598
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Walnut Creek, CA
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