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Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

Children's Hospital of Philadelphia (CHOP) logo

Children's Hospital of Philadelphia (CHOP)

Status

Withdrawn

Conditions

Diabetes

Treatments

Drug: Repaglinide and Insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT00231192
2005-8-4323
Cystic Fibrosis Foundation

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

12 to 20 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Cystic Fibrosis, Blood glucose concerning for diabetes -

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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