Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

October 27, 2015 updated by: Karen Jones, Royal Adelaide Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Discipline of Medicine, Royal Adelaide Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo (sugar pill)
Inactive drug (placebo)
Drug: Placebo
100mg mane for 2 days
EXPERIMENTAL: Sitagliptin (100mg)
Active drug (sitagliptin)
Drug: Sitagliptin
100mg mane for 2 days
Other Names:
  • Januvia
  • MK-0431-075

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastric emptying rate
Time Frame: 4 hours per study
4 hours per study

Secondary Outcome Measures

Outcome Measure
Time Frame
Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite
Time Frame: 4 hours per study
4 hours per study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Adelaide Hospital

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Karen L Jones, PhD, University of Adelaide, Royal Adelaide Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

July 13, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (ESTIMATE)

July 16, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 061025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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