NCT00231192

Brief Summary

This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD in adolescents. In addition, successful treatment of CFRD with repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and will not have a negative impact upon quality of life.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 1, 2005

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 12, 2015

Status Verified

November 1, 2007

First QC Date

October 3, 2005

Last Update Submit

March 11, 2015

Conditions

Diabetes

Keywords

DiabetesAdolescentsCystic FibrosisInsulinRepaglinide

Outcome Measures

Primary Outcomes (6)

  • blood glucose

  • insulin excursion during oral glucose tolerance test

  • fasting blood glucose

  • 2-hour post-prandial blood glucose

  • hemoglobin A1C

  • serum fructosamine

Secondary Outcomes (5)

  • weight

  • body mass index

  • lean body mass

  • pulmonary function

  • quality of life

Interventions

Repaglinide and InsulinDRUG

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Cystic Fibrosis, Blood glucose concerning for diabetes -

You may not qualify if:

  • Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1\<40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4399, United States

Location

MeSH Terms

Conditions

Diabetes MellitusCystic FibrosisInsulin Resistance

Interventions

repaglinideInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Andrea Kelly, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Study Start

October 1, 2005

Study Completion

August 1, 2007

Last Updated

March 12, 2015

Record last verified: 2007-11

Locations

US(1)