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The Effects of LAF237 on Gastric Function in Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes Mellitus, Non-Insulin-Dependent
Registration Number
NCT00952991
Lead Sponsor
Mayo Clinic
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
Inclusion Criteria
  • Type 2 diabetes without microvascular or macrovascular complications treated with diet or up to 2 oral agents
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Gastric Emptying
Gastric accommodation
Satiety
Gastrointestinal Symptoms
Secondary Outcome Measures
NameTimeMethod
Meal Appearance Rate
Glucose Disappearance
Endogenous Glucose Production
Insulin Secretion
Glucagon Secretion

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

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