Treatment With Sitagliptin for Reactive Hypoglycemia Seco... | NCT00847080

Studies
Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism

NCT00847080

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Completed

Last Update Posted

Apr 26, 2011Estimated

Enrollment

20Actual

Phase

Phase 4

Conditions

Reactive Hypoglycemia

Interventions

Sitagliptin phosphate
Placebo

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2010Actual

Completion Date

Mar 2011Actual

First Submitted Date

Feb 18, 2009

First Submission Date that Met QC Criteria

Feb 18, 2009

First Posted Date

Feb 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2011

Last Update Posted Date

Apr 26, 2011Estimated

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sitagliptin	Experimental		Drug: Sitagliptin phosphate
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin phosphate	Drug	Sitagliptin phosphate 100 mg per day per 2 weeks	Sitagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical improvement assessed by a validated questionnaire		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Glucose, insulin, GLP1, GIP		First and last evaluations

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francisco J Gomez-Perez, MD	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran		Mexico City	Mexico City	14000	Mexico

References Module

Citations

Not provided

Label	URL
Click here for information of the study location	View source
Click here for information of study sponsor in english	View source

ID	Term
D007003	Hypoglycemia
D011236	Prediabetic State

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D003920	Diabetes Mellitus

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds