A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT00477581
Last Updated: 2015-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
102 participants
INTERVENTIONAL
2007-05-31
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Sequence A
exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
sitagliptin
oral administration (100mg), once a day in the morning
Sequence B
exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
sitagliptin
oral administration (100mg), once a day in the morning
Interventions
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exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
sitagliptin
oral administration (100mg), once a day in the morning
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has HbA1c 7.0% to 11.0%, inclusive, at screening
* Body mass index (BMI)25 kg/m\^2 to 45 kg/m\^2, inclusive
* List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:
* Hormone replacement therapy (female subjects)
* Oral contraceptives (female subjects)
* Antihypertensive agents
* Lipid-lowering agents
* Thyroid replacement therapy
Exclusion Criteria
* Received any study medication or participated in any type of clinical trial within 30 days prior to screening
* Has donated blood within 60 days of screening visit or is planning to donate blood during the study
* Treated with any of the following medications:
* Sulfonylurea or Thiazolidinedione within 3 months of screening;
* Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)within 30 days of screening;
* Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening;
* Drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and Reglan®(metoclopramide);
* Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption;
18 Years
70 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Porter, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Los Angeles, California, United States
Research Site
Spring Valley, California, United States
Research Site
Miami, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Detroit, Michigan, United States
Research Site
Butte, Montana, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Eugene, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Charleston, South Carolina, United States
Research Site
Greer, South Carolina, United States
Research Site
Austin, Texas, United States
Research Site
Corpus Christi, Texas, United States
Research Site
San Antonio, Texas, United States
Countries
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References
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DeFronzo RA, Okerson T, Viswanathan P, Guan X, Holcombe JH, MacConell L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin. 2008 Oct;24(10):2943-52. doi: 10.1185/03007990802418851. Epub 2008 Sep 10.
Other Identifiers
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BCA403
Identifier Type: -
Identifier Source: org_study_id
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