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Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Karen Jones, Royal Adelaide Hospital
ClinicalTrials.gov Identifier:
NCT00501657
First received: July 13, 2007
Last updated: August 22, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Gastroparesis
Diabetes Mellitus
 Drug: Sitagliptin
 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:

U.S. FDA Resources

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
Estimated 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: Sitagliptin
100mg mane for 2 days
Other Name: Placebo

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.

  Eligibility

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

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

Locations
Australia, South Australia
Discipline of Medicine, Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Royal Adelaide Hospital
Merck
Investigators
Principal Investigator: Karen L Jones, PhD University of Adelaide, Royal Adelaide Hospital
  More Information

No publications provided by Royal Adelaide Hospital

Additional 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, P2131
Study First Received: July 13, 2007
Last Updated: August 22, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Royal Adelaide Hospital:
gastric emptying
glycemia
appetite
incretin hormones

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

ClinicalTrials.gov processed this record on May 19, 2013