Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Reactive Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sitagliptin

Group Type EXPERIMENTAL

Sitagliptin phosphate

Intervention Type DRUG

Sitagliptin phosphate 100 mg per day per 2 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 tablet per day per 2 weeks

Interventions

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Sitagliptin phosphate

Sitagliptin phosphate 100 mg per day per 2 weeks

Intervention Type DRUG

Placebo

Placebo 1 tablet per day per 2 weeks

Intervention Type DRUG

Other Intervention Names

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Januvia

Eligibility Criteria

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Inclusion Criteria

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