Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2013
End Date:April 2014

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A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once
weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in
subjects with type 2 diabetes mellitus.


Inclusion Criteria:

- At least 18 years old

- Diagnosed with type 2 diabetes mellitus

- HbA1c of 7.1% to 11.0%, inclusive, at screening

- Has stable body weight, i.e., not varying by >3% for at least 3 months prior to
screening

- Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening

- Body mass index of <45 kg/m2 at screening

- Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2
months prior to Visit 1 (Screening)

Exclusion Criteria:

- History of pancreatitis or triglycerides >=500 mg/dL

- Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of
either

- History of renal transplantation, or is currently receiving renal dialysis, or has an
estimated creatinine clearance <50 mL/min

- Active cardiovascular disease

- Presence or history of severe congestive heart failure

- Central nervous system disease, including epilepsy

- Liver disease

- History of severe gastrointestinal diseases

- Clinically significant malignant disease

- Repeated severe hypoglycemia within the last 6 months

- Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog

- Any DPP-4 inhibitor within 3 months prior screening
We found this trial at
53
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Greensboro, North Carolina 27401
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Albuquerque, NM
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Beverly Hills, California 90211
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Birmingham, AL
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Boca Raton, FL
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Buena Park, CA
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Buffalo, NY
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Burke, VA
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Carrolton, TX
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Charlotte, North Carolina 28207
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Chattanooga, TN
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Chicago, IL
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Cincinnati, OH
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Clayton, NC
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Dallas, TX
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Durham, NC
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Encinitas, CA
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Eugene, OR
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Evanston, IL
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420 West 12th Avenue
Franklin, Ohio 43210
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Greenbrae, CA
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Hartsdale, NY
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Houston, TX
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Indianapolis, IN
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Las Vegas, NV
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Marion, OH
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Miami, FL
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Mooresville, North Carolina 28117
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North Hollywood, California 91606
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North Hollywood, CA
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Omaha, NE
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Rapid City, South Dakota 57702
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Salisbury, North Carolina 28144
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Salt Lake City, UT
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Yukon, OK
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