Diabetes Therapy to Improve BMI and Lung Function in CF

Diabetes Mellitus Clinical Trial

Official title:

Diabetes Therapy to Improve BMI and Lung Function in CF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072904
• Other study ID #: 58356DK (completed)
• Status: Completed
• Phase: Phase 3
• First received: November 12, 2003
• Last updated: February 27, 2012
• Start date: June 2001
• Est. completion date: December 2007

Study information

• Verified date: February 2012
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

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.

Other known NCT identifiers

• NCT00177151

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Diabetes Mellitus

Intervention

Drug:
• Insulin Asparte
Insulin asparte given 0.5 units per carb per meal
• Repaglinide
0.5mg tab with meals tid

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Stanford University	Palo Alto	California
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Cystic Fibrosis Foundation Therapeutics, Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 cy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 months	Yes