Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

Reactive Hypoglycemia Clinical Trial

Official title:

Treatment With Sitagliptin Phosphate in Patients With Reactive Hypoglycemia Secondary to Dysinsulinism. A Controlled, Randomized, Double-blind, Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847080
• Other study ID #: MK-0431
• Status: Completed
• Phase: Phase 4
• First received: February 18, 2009
• Last updated: April 22, 2011
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: February 2009
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoglycemia
• Reactive Hypoglycemia

Intervention

Drug:
• Sitagliptin phosphate
Sitagliptin phosphate 100 mg per day per 2 weeks
• Placebo
Placebo 1 tablet per day per 2 weeks

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico	DF

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement assessed by a validated questionnaire		2 weeks	No
Secondary	Glucose, insulin, GLP1, GIP		First and last evaluations	No

External Links

•   Click here for information of study sponsor in english
•   Click here for information of study sponsor in spanish
•   Click here for information of the study location