Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Investigators
Principal Investigator: Francisco J Gomez-Perez, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  More Information

Additional Information:
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014