A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
102
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes-mellitus
Started May 2007
Shorter than P25 for phase_4 type-2-diabetes-mellitus
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 21, 2007
CompletedFirst Posted
Study publicly available on registry
May 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedAugust 26, 2015
August 1, 2015
4 months
May 21, 2007
August 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of Exenatide on postprandial glucose
To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus
28 days
Secondary Outcomes (1)
Assessment of effect of exenatide to the effect of sitagliptin the acetaminophen absorption test, and 6-point self-monitored blood glucose (SMBG) profiles
28 days
Study Arms (2)
Sequence A
EXPERIMENTALSequence B
EXPERIMENTALInterventions
subcutaneous injection (5mcg or 10mcg), twice a day
oral administration (100mg), once a day in the morning
Eligibility Criteria
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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (19)
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, 46260, 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
Related Publications (1)
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.
PMID: 18786299DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2007
First Posted
May 23, 2007
Study Start
May 1, 2007
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
August 26, 2015
Record last verified: 2015-08