Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00501657
Study type	Interventional
Source	Royal Adelaide Hospital
Contact
Status	Completed
Phase	Phase 1
Start date	July 2007
Completion date	December 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03743779` - Mastering Diabetes Pilot Study
Completed	`NCT03786978` - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus	N/A
Completed	`NCT01804803` - DIgital Assisted MONitoring for DiabeteS - I	N/A
Completed	`NCT05039970` - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT04068272` - Safety of Bosentan in Type II Diabetic Patients	Phase 1
Completed	`NCT03243383` - Readmission Prevention Pilot Trial in Diabetes Patients	N/A
Completed	`NCT03730480` - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)	N/A
Recruiting	`NCT02690467` - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.	N/A
Completed	`NCT02229383` - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus	Phase 3
Completed	`NCT06181721` - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes	N/A
Completed	`NCT05799976` - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure	N/A
Recruiting	`NCT04489043` - Exercise, Prediabetes and Diabetes After Renal Transplantation.	N/A
Withdrawn	`NCT03319784` - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients	Phase 4
Completed	`NCT03542084` - Endocrinology Auto-Triggered e-Consults	N/A
Completed	`NCT02229396` - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo	Phase 3
Recruiting	`NCT05544266` - Rare and Atypical Diabetes Network
Completed	`NCT01892319` - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed	`NCT05031000` - Blood Glucose Monitoring Systems: Discounter Versus Brand	N/A
Recruiting	`NCT04039763` - RT-CGM in Young Adults at Risk of DKA	N/A