A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

Completed · Phase 4

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00477581

Run by

AstraZeneca

People needed

102

Starts

2007-05-01

Expected to finish

2007-09-01

Last updated by the study team

2015-08-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• 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

Full record on ClinicalTrials.gov

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