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Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT00847080
First received: February 18, 2009
Last updated: April 22, 2011
Last verified: February 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Reactive Hypoglycemia
 Drug: Sitagliptin phosphate
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment With Sitagliptin Phosphate in Patients With Reactive Hypoglycemia Secondary to Dysinsulinism. A Controlled, Randomized, Double-blind, Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Clinical improvement assessed by a validated questionnaire [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucose, insulin, GLP1, GIP [ Time Frame: First and last evaluations ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin Drug: Sitagliptin phosphate
Sitagliptin phosphate 100 mg per day per 2 weeks
Other Name: Januvia
Placebo Comparator: Placebo Drug: Placebo
Placebo 1 tablet per day per 2 weeks
Other Name: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847080

Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico, DF, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Merck
Investigators
Principal Investigator: Francisco J Gomez-Perez, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  More Information

Additional Information:
Click here for information of the study location  This link exits the ClinicalTrials.gov site
Click here for information of study sponsor in spanish  This link exits the ClinicalTrials.gov site
Click here for information of study sponsor in english  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Francisco J Gomez-Perez, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT00847080     History of Changes
Other Study ID Numbers: MK-0431
Study First Received: February 18, 2009
Last Updated: April 22, 2011
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Reactive hypoglycemia
Sitagliptin
Glucagon-Like Peptide 1
Incretins
Prediabetes

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013