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Salt Lake City, Utah 84132

  • Diabetes Mellitus

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).


Study summary:

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.


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


Study is Available At:


Original ID:

58356DK (completed)


NCT ID:

NCT00072904


Secondary ID:


Study Acronym:


Brief Title:

Diabetes Therapy to Improve BMI and Lung Function in CF


Official Title:

Diabetes Therapy to Improve BMI and Lung Function in CF


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

16 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

108


Enrollment Type:

Actual


Overall Contact Information

Official Name:Antoinette Moran, MD
Principal Investigator
University of Minnesota - Clinical and Translational Science Institute

Study Dates

Start Date:June 2001
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:February 2012
Last Changed Date:February 27, 2012
First Received Date:November 12, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Insulin Asparte
Description:Insulin asparte given 0.5 units per carb per meal
Arm Name:III
Intervention Type:Drug
Name:Repaglinide
Description:0.5mg tab with meals tid
Arm Name:III

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:III
Description:Placebo take half tab with meals tid

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Agency Class:Other
Agency Type:Collaborator
Agency Name:Cystic Fibrosis Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:19592632

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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