Diabetes Therapy to Improve BMI and Lung Function in CF

NCT00072904 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2012-02-28

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Insulin Asparte

Insulin asparte given 0.5 units per carb per meal

DRUG

Repaglinide

0.5mg tab with meals tid

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER
  • Novo Nordisk A/S

    collaborator INDUSTRY
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Antoinette Moran, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00072904 on ClinicalTrials.gov