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Insulin
Cystic Fibrosis - Insulin Deficiency, Early Action (CF-IDEA Trial)
Phase 3
Waitlist Available
Led By Charles Verge, MBBS PhD
Research Sponsored by Sydney Children's Hospitals Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing if giving insulin to children with Cystic Fibrosis who show early signs of insulin deficiency can improve their weight and lung function. The goal is to start treatment before diabetes fully develops to maintain better health. Insulin is the only currently recommended therapy for all types of cystic fibrosis-related diabetes (CFRD).
Eligible Conditions
- Cystic Fibrosis
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Body composition by DEXA. Patients at CHW will also have pQCT.
Change in effort-dependent lung function: MIP, MEP, SnIP
Change in glycaemic status assessed by HbA1c and CGM
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Once-daily insulin detemirExperimental Treatment1 Intervention
Once-daily insulin detemir
Group II: Control groupActive Control1 Intervention
Observation only. Does not receive once-daily insulin detemir.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin detemir
FDA approved
Find a Location
Who is running the clinical trial?
Sydney Children's Hospitals NetworkLead Sponsor
36 Previous Clinical Trials
43,250 Total Patients Enrolled
John Hunter Children's HospitalOTHER
3 Previous Clinical Trials
220 Total Patients Enrolled
Lady Cilento Children's Hospital, BrisbaneOTHER
1 Previous Clinical Trials
150 Total Patients Enrolled
Women's and Children's Hospital, AdelaideUNKNOWN
1 Previous Clinical Trials
450 Total Patients Enrolled
Children's Hospital ColoradoOTHER
120 Previous Clinical Trials
5,133,091 Total Patients Enrolled
6 Trials studying Cystic Fibrosis
894 Patients Enrolled for Cystic Fibrosis
Charles Verge, MBBS PhDPrincipal InvestigatorEndocrinology, Sydney Children's Hospital Randwick; School of Women's and Children's Health, University of NSW