Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate at which the stomach empties, and the release of gut hormones and blood glucose concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to reduce the blood glucose (sugar) response to a meal and this may potentially be due to slowing of stomach emptying. This is particularly relevant to people who have diabetes, in whom normalization of elevated blood glucose levels is important to maintain health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 13, 2007
CompletedFirst Posted
Study publicly available on registry
July 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedOctober 29, 2015
December 1, 2014
11 months
July 13, 2007
October 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastric emptying rate
4 hours per study
Secondary Outcomes (1)
Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite
4 hours per study
Study Arms (2)
Sitagliptin (100mg)
EXPERIMENTALActive drug (sitagliptin)
Placebo (sugar pill)
PLACEBO COMPARATORInactive drug (placebo)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female (females must be using an appropriate contraceptive method)
- years
- Body mass index (BMI) 19 - 25 kg/m2.
You may not qualify if:
- Subjects with gastrointestinal disease, history of gastrointestinal surgery and/or significant gastrointestinal symptoms
- Subjects taking medication known to influence gastrointestinal function
- Alcohol intake \> 20 g per day
- Smoking \> 10 cigarettes per day
- Pregnant and/or lactating females
- Calculated creatinine clearance \< 60 ml/min
- Exposure to ionising radiation for research purposes in the previous 12 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Adelaide Hospitallead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Discipline of Medicine, Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Related Publications (1)
Stevens JE, Horowitz M, Deacon CF, Nauck M, Rayner CK, Jones KL. The effects of sitagliptin on gastric emptying in healthy humans - a randomised, controlled study. Aliment Pharmacol Ther. 2012 Aug;36(4):379-90. doi: 10.1111/j.1365-2036.2012.05198.x. Epub 2012 Jun 28.
PMID: 22738299DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen L Jones, PhD
University of Adelaide, Royal Adelaide Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 13, 2007
First Posted
July 16, 2007
Study Start
July 1, 2007
Primary Completion
June 1, 2008
Study Completion
December 1, 2011
Last Updated
October 29, 2015
Record last verified: 2014-12