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Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

Primary Purpose

Reactive Hypoglycemia

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Sitagliptin phosphate
Placebo
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reactive Hypoglycemia focused on measuring Reactive hypoglycemia, Sitagliptin, Glucagon-Like Peptide 1, Incretins, Prediabetes

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sitagliptin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Clinical improvement assessed by a validated questionnaire

Secondary Outcome Measures

Glucose, insulin, GLP1, GIP

Full Information

First Posted
February 18, 2009
Last Updated
April 22, 2011
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00847080
Brief Title
Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism
Official Title
Treatment With Sitagliptin Phosphate in Patients With Reactive Hypoglycemia Secondary to Dysinsulinism. A Controlled, Randomized, Double-blind, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reactive Hypoglycemia
Keywords
Reactive hypoglycemia, Sitagliptin, Glucagon-Like Peptide 1, Incretins, Prediabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sitagliptin phosphate
Other Intervention Name(s)
Januvia
Intervention Description
Sitagliptin phosphate 100 mg per day per 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 tablet per day per 2 weeks
Primary Outcome Measure Information:
Title
Clinical improvement assessed by a validated questionnaire
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Glucose, insulin, GLP1, GIP
Time Frame
First and last evaluations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J Gomez-Perez, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

Links:
URL
http://www.innsz.mx/opencms/contenido/english.html
Description
Click here for information of the study location
URL
http://www.merck.com/
Description
Click here for information of study sponsor in english

Learn more about this trial

Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

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