Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501657
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : October 29, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Karen Jones, Royal Adelaide Hospital

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.

Condition or disease Intervention/treatment Phase
Gastroparesis Diabetes Mellitus Drug: Sitagliptin Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Study Start Date : July 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Gastric emptying rate [ Time Frame: 4 hours per study ]

Secondary Outcome Measures :
  1. Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite [ Time Frame: 4 hours per study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Karen Jones, Professor, Royal Adelaide Hospital Identifier: NCT00501657     History of Changes
Other Study ID Numbers: 061025
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: December 2014

Keywords provided by Karen Jones, Royal Adelaide Hospital:
gastric emptying
incretin hormones

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action