Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Karen Jones, Royal Adelaide Hospital
ClinicalTrials.gov Identifier:
NCT00501657
First received: July 13, 2007
Last updated: November 5, 2013
Last verified: November 2013

July 13, 2007
November 5, 2013
July 2007
June 2008   (final data collection date for primary outcome measure)
Gastric emptying rate [ Time Frame: 4 hours per study ] [ Designated as safety issue: No ]
Gastric emptying rate [ Time Frame: 4 hours per study ]
Complete list of historical versions of study NCT00501657 on ClinicalTrials.gov Archive Site
Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite [ Time Frame: 4 hours per study ] [ Designated as safety issue: No ]
Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite [ Time Frame: 4 hours per study ]
Not Provided
Not Provided
 
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Gastroparesis
  • Diabetes Mellitus
  • Drug: Sitagliptin
    100mg mane for 2 days
    Other Names:
    • MK-0431-075
    • Januvia
  • Drug: Sitagliptin
    100mg mane for 2 days
    Other Name: Placebo
  • Experimental: Sitagliptin (100mg)
    Active drug (sitagliptin)
    Intervention: Drug: Sitagliptin
  • Placebo Comparator: Placebo (sugar pill)
    Inactive drug (placebo)
    Intervention: Drug: Sitagliptin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2011
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00501657
061025, P2131
No
Karen Jones, Royal Adelaide Hospital
Royal Adelaide Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Karen L Jones, PhD University of Adelaide, Royal Adelaide Hospital
Royal Adelaide Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP