NCT00847080

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 26, 2011

Status Verified

February 1, 2009

Enrollment Period

2 years

First QC Date

February 18, 2009

Last Update Submit

April 22, 2011

Conditions

Reactive Hypoglycemia

Keywords

Reactive hypoglycemiaSitagliptinGlucagon-Like Peptide 1IncretinsPrediabetes

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement assessed by a validated questionnaire

    2 weeks

Secondary Outcomes (1)

  • Glucose, insulin, GLP1, GIP

    First and last evaluations

Study Arms (2)

Sitagliptin

EXPERIMENTAL
Drug: Sitagliptin phosphate

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Sitagliptin phosphateDRUG

Sitagliptin phosphate 100 mg per day per 2 weeks

Also known as: Januvia
Sitagliptin
PlaceboDRUG

Placebo 1 tablet per day per 2 weeks

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

Location

Related Links

MeSH Terms

Conditions

HypoglycemiaPrediabetic State

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Francisco J Gomez-Perez, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

April 26, 2011

Record last verified: 2009-02

Locations

ME(1)