Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Karen Jones, Royal Adelaide Hospital
ClinicalTrials.gov Identifier:
First received: July 13, 2007
Last updated: October 27, 2015
Last verified: December 2014
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.

Condition Intervention Phase
Diabetes Mellitus
Drug: Sitagliptin
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by Royal Adelaide Hospital:

Primary Outcome Measures:
  • Gastric emptying rate [ Time Frame: 4 hours per study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite [ Time Frame: 4 hours per study ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2007
Study Completion Date: December 2011
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin (100mg)
Active drug (sitagliptin)
Drug: Sitagliptin
100mg mane for 2 days
Other Names:
  • MK-0431-075
  • Januvia
Placebo Comparator: Placebo (sugar pill)
Inactive drug (placebo)
Drug: Placebo
100mg mane for 2 days

Detailed Description:

The purpose of this study is to evaluate the effect of sitagliptin on gastric emptying, intragastric meal distribution, postprandial glycemia and insulinemia in healthy subjects. Glucagon-like peptide-1 (GLP-1) inhibits gastric emptying, thereby slowing the delivery of nutrients, and their absorption, across the small intestine. The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycemic response to, a carbohydrate-containing meal.

Fifteen healthy subjects (male and female) will be studied. Each subject will be studied on two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching placebo in a randomized, double blind, crossover design. Measurements of gastric emptying, intragastric meal distribution, blood glucose concentrations, gut hormones and appetite will be measured for 4 hours following ingestion of a mashed potato meal.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or female (females must be using an appropriate contraceptive method)
  • 18 - 45 years
  • Body mass index (BMI) 19 - 25 kg/m2.

Exclusion criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501657

Australia, South Australia
Discipline of Medicine, Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Royal Adelaide Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Karen L Jones, PhD University of Adelaide, Royal Adelaide Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Jones, Professor, Royal Adelaide Hospital
ClinicalTrials.gov Identifier: NCT00501657     History of Changes
Other Study ID Numbers: 061025 
Study First Received: July 13, 2007
Last Updated: October 27, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Royal Adelaide Hospital:
gastric emptying
incretin hormones

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Neurologic Manifestations
Signs and Symptoms
Stomach Diseases
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on May 05, 2016