A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 4/21/2016 |
Start Date: | May 2007 |
End Date: | September 2007 |
A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
This purpose of this study is to compare the effect of exenatide to that of sitagliptin on
2-hour postprandial glucose in subjects with type 2 diabetes mellitus.
2-hour postprandial glucose in subjects with type 2 diabetes mellitus.
Inclusion Criteria:
- Treatment with metformin for at least 2 months
- 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
- Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening
- 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;
We found this trial at
18
sites
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