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Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00231192
Enrollment
0
Registered
2005-10-04
Start date
2005-10-31
Completion date
2007-08-31
Last updated
2015-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Adolescents, Cystic Fibrosis, Insulin, Repaglinide

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.

Interventions

DRUGRepaglinide and Insulin

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

Cystic Fibrosis, Blood glucose concerning for diabetes -

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026