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CompletedNCT00847080Updated Apr 26, 2011

Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

A Phase 4 interventional study of Sitagliptin phosphate and Placebo in Reactive Hypoglycemia, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Completed at 1 site in Mexico. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2011-04-26.

Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Reactive Hypoglycemia

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Keywords

  • Reactive hypoglycemia
  • Sitagliptin
  • Glucagon-Like Peptide 1
  • Incretins
  • Prediabetes
03

In context

Hypoglycemia

640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's enrollment of 20 is below the median of 29 across 471 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 141 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Renal insufficiency
  • Hepatic insufficiency
  • Diabetes (any type)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Sitagliptin

    Drug: Sitagliptin phosphate

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSitagliptin phosphate

    Sitagliptin phosphate 100 mg per day per 2 weeks

    Also known as: Januvia

  • DrugPlacebo

    Placebo 1 tablet per day per 2 weeks

06

What researchers measure

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

07

Study locations

1 site
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    Mexico, DF 14000, Mexico
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00847080
Lead sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Merck Sharp & Dohme LLC
First posted
Feb 19, 2009
Start date
Dec 2008
Primary completion
Dec 2010
Completion
Mar 2011
Last update
Apr 26, 2011

Study contacts

Francisco J Gomez-Perez, MD
principal investigator · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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