Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

This study has been terminated.
(Unable to recruit any subjects)
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00231192
First received: October 3, 2005
Last updated: November 13, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention
Diabetes
Drug: Repaglinide and Insulin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

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

Enrollment: 0
Study Start Date: October 2005
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Cystic Fibrosis, Blood glucose concerning for diabetes -

Exclusion Criteria:

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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231192

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4399
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Andrea Kelly, MD Children's Hospital of Philadelphia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00231192     History of Changes
Other Study ID Numbers: 2005-8-4323, Cystic Fibrosis Foundation
Study First Received: October 3, 2005
Last Updated: November 13, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Diabetes
Adolescents
Cystic Fibrosis
Insulin
Repaglinide

Additional relevant MeSH terms:
Cystic Fibrosis
Diabetes Mellitus
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Repaglinide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014