Diabetes Therapy to Improve BMI and Lung Function in CF

This study has been completed.
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Novo Nordisk A/S
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00072904
First received: November 12, 2003
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).


Condition Intervention Phase
Cystic Fibrosis
Diabetes Mellitus
Drug: Insulin Asparte
Drug: Repaglinide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diabetes Therapy to Improve BMI and Lung Function in CF

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 108
Study Start Date: June 2001
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: III
Placebo take half tab with meals tid
Drug: Insulin Asparte
Insulin asparte given 0.5 units per carb per meal
Drug: Repaglinide
0.5mg tab with meals tid

Detailed Description:

The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes without fasting hyperglycemia.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • Diabetic glucose pattern by oral glucose tolerance test (OGTT) of >200 at 120 min. (stable and healthy at time of OGTT)
  • Fasting glucose levels <126.
  • Weight stable within 5% in previous 3 months.
  • Free from illness for two months.
  • Male and female 16 and older, who are done growing
  • Willing to come in for visits every 3 months.
  • Patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study inclusion if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months
  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: NCT00072904

Locations
United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2583
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2650
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132-4701
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Cystic Fibrosis Foundation
Novo Nordisk A/S
Investigators
Principal Investigator: Antoinette Moran, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: Antoinette Moran, University Of Minnesota
ClinicalTrials.gov Identifier: NCT00072904     History of Changes
Obsolete Identifiers: NCT00177151
Other Study ID Numbers: 58356DK (completed)
Study First Received: November 12, 2003
Last Updated: February 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Cystic Fibrosis Related Diabetes
Diabetes without Fasting Hyperglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Fibrosis
Cystic Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014