NCT00072904

Diabetes Therapy to Improve BMI and Lung Function in CF

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cystic Fibrosis
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin Asparte	Insulin asparte given 0.5 units per carb per meal
DRUG	Repaglinide	0.5mg tab with meals tid

Timeline

• Start date: 2001-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2003-11-14
• Last updated: 2012-02-28

Locations

7 sites across 2 countries: United States, Canada