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Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

Primary Purpose

Diabetes

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repaglinide and Insulin
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Adolescents, Cystic Fibrosis, Insulin, Repaglinide

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Cystic Fibrosis, Blood glucose concerning for diabetes - Exclusion Criteria: Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1<40% -

Sites / Locations

  • The Children's Hospital of Philadelphia

Outcomes

Primary Outcome Measures

blood glucose
insulin excursion during oral glucose tolerance test
fasting blood glucose
2-hour post-prandial blood glucose
hemoglobin A1C
serum fructosamine

Secondary Outcome Measures

weight
body mass index
lean body mass
pulmonary function
quality of life

Full Information

First Posted
October 3, 2005
Last Updated
March 11, 2015
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT00231192
Brief Title
Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes
Official Title
Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit any subjects
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD. This hypothesis will be tested using the following aims: Specific Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon blood glucose (BG) and insulin excursion during an oral glucose tolerance test. Specific Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon BG as measured by continuous glucose monitoring, fasting BG, 2-hour post-prandial BG, hemoglobin A1C, and serum fructosamine. Secondary Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon weight, body mass index, and lean body mass in adolescents with new-onset CFRD. Secondary Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon pulmonary function in adolescents with new-onset CFRD. Secondary Aim 3: To determine the effect of three months of repaglinide and insulin treatment upon quality of life in new-onset CFRD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Diabetes, Adolescents, Cystic Fibrosis, Insulin, Repaglinide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Repaglinide and Insulin
Primary Outcome Measure Information:
Title
blood glucose
Title
insulin excursion during oral glucose tolerance test
Title
fasting blood glucose
Title
2-hour post-prandial blood glucose
Title
hemoglobin A1C
Title
serum fructosamine
Secondary Outcome Measure Information:
Title
weight
Title
body mass index
Title
lean body mass
Title
pulmonary function
Title
quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cystic Fibrosis, Blood glucose concerning for diabetes - Exclusion Criteria: Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1<40% -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Kelly, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4399
Country
United States

12. IPD Sharing Statement

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Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

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