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Hormone Therapy
basal insulin levemir for Cystic Fibrosis
Phase 2 & 3
Waitlist Available
Led By Antoinette Moran, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of cystic fibrosis, age 10-25 years
A standard routine annual OGTT performed within 12 months of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 hour meal study
Awards & highlights
Study Summary
This trial suggests that insulin therapy may help improve the health of pre-diabetic, insulin insufficient CF patients by reducing protein catabolism and undernutrition.
Eligible Conditions
- Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 hour meal study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 hour meal study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
post-prandial protein turnover
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: rapid-acting insulin NovologExperimental Treatment1 Intervention
pre-meal rapid-acting insulin 3x/day with insulin novolog
Group II: basal insulin levemirExperimental Treatment1 Intervention
once daily basal insulin therapy with insulin levemir
Group III: placeboPlacebo Group1 Intervention
once or 3x daily injectable placebo (insulin diluent)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
novolog insulin
2015
Completed Phase 3
~70
levemir insulin
2015
Completed Phase 3
~70
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,367 Previous Clinical Trials
1,587,443 Total Patients Enrolled
14 Trials studying Cystic Fibrosis
2,330 Patients Enrolled for Cystic Fibrosis
Antoinette Moran, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
468 Total Patients Enrolled
3 Trials studying Cystic Fibrosis
278 Patients Enrolled for Cystic Fibrosis
Frequently Asked Questions
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