Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Completed; Phase 4

Conditions: Reactive Hypoglycemia

Treatments: Drug: Placebo; Drug: Sitagliptin phosphate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00847080

MK-0431

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Sitagliptin

Experimental group

Treatment:

Drug: Sitagliptin phosphate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo