Diabetes Therapy to Improve BMI and Lung Function in CF

Phase 3

Completed

• Conditions: Cystic Fibrosis; Diabetes Mellitus
• Interventions: Drug: Insulin Asparte; Drug: Repaglinide

• Registration Number: NCT00072904
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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).

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.

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2003-11-12
• Study First Submitted QC: 2003-11-13
• Study First Posted: 2003-11-14
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
III	Repaglinide	Placebo take half tab with meals tid
III	Insulin Asparte	Placebo take half tab with meals tid

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Stanford University; 🇺🇸 Palo Alto, California, United States