Diabetes Therapy to Improve BMI and Lung Function in CF

This study has been completed.

First Received on November 12, 2003. Last Updated on February 12, 2010 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:	Cystic Fibrosis Foundation Novo Nordisk
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00072904

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 III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Diabetes Medicines

Drug Information available for: Insulin Insulin beef AG-EE 388 ZW

U.S. FDA Resources

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

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Cystic Fibrosis Foundation

Novo Nordisk

Investigators

Principal Investigator:

Antoinette Moran, MD

University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moran A, Pekow P, Grover P, Zorn M, Slovis B, Pilewski J, Tullis E, Liou TG, Allen H; Cystic Fibrosis Related Diabetes Therapy Study Group. Insulin therapy to improve BMI in cystic fibrosis-related diabetes without fasting hyperglycemia: results of the cystic fibrosis related diabetes therapy trial. Diabetes Care. 2009 Oct;32(10):1783-8. Epub 2009 Jul 10.

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 12, 2010
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:

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 February 12, 2012