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Completed

NCT Number: NCT00847080

Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

The purpose of this study is to determine whether sitagliptin is effective in the treatment of reactive hypoglycemia by dysinsulinism.

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Key information

Conditions

Reactive Hypoglycemia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14000, Mexico

About this study

Symptomatic reactive hypoglycemia is an abnormal glucose decrease after meal ingestion. Patients with this abnormality as an early manifestation of glucose intolerance are at higher risk of type 2 diabetes. The pathophysiology of this abnormality appears to be related with delayed first phase insulin release. Improvement of first phase insulin secretion and delay in gastric emptying induced by sitagliptin phosphate could have favorable effects in patients in whom delayed insulin secretion is associated with reactive hypoglycemia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical and biochemical diagnosis of prediabetic reactive hypoglycemia
  • Must be able to swallow tablet
  • Negative pregnancy test (when appropriate)

Exclusion criteria

  • Renal insufficiency
  • Hepatic insufficiency
  • Diabetes (any type)

Treatment and study plan

sitagliptin phosphate

Drug

Sitagliptin phosphate 100 mg per day per 2 weeks

Other names: Januvia

Placebo

Drug

Placebo 1 tablet per day per 2 weeks

Primary outcomes

  1. Clinical improvement assessed by a validated questionnaire

    Time frame: 2 weeks

Secondary outcomes

  1. Glucose, insulin, GLP1, GIP

    Time frame: First and last evaluations

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Treatment With Sitagliptin Phosphate in Patients With Reactive Hypoglycemia Secondary to Dysinsulinism. A Controlled, Randomized, Double-blind, Clinical Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 19, 2009
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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