Diabetes Therapy to Improve BMI and Lung Function in CF
This study has been completed.
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Novo Nordisk
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
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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
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
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:
|
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 May 19, 2013