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The Effects of LAF237 on Gastric Function in Type 2 Diabetes

NCT00952991 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-03-23

No results posted yet for this study

Summary

Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D). However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be administered by continuous intravenous infusion. This would be a drawback in clinical usage. LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of this compound on postprandial glucose metabolism.

Conditions

  • Diabetes Mellitus, Non-Insulin-Dependent

Interventions

DRUG

LAF237 = vildagliptin

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00952991 on ClinicalTrials.gov