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Grafalon®therapy within 12 weeks of Type 1 diabetes (T1D) diagnosis in children and young adults to prevent the loss of residual beta cell function: a randomised, double-blind, placebo-controlled dose finding study Acronym: GIRO T1D

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508514-42-00
Acronym
GIRO T1D
Enrollment
18
Registered
2024-01-11
Start date
2024-06-04
Completion date
Unknown
Last updated
2024-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes

Brief summary

AUC0-2h for a mixed meal tolerance test (MMTT) stimulated C-peptide concentration-time curve (C-peptideAUC) at 12 months relative to baseline

Detailed description

Peak MMTT stimulated C-peptide concentration (C-peptidemax) at months 6, 12 and 24 relative to baseline Change in fasting C-peptide from baseline to months 6 and 12 Change in HbA1c from baseline to month 12 HbA1c at 12 and 24 months Change in fasting plasma glucose from baseline to month 12 Total insulin treatment administered over the period of 12 months calculated as AUC (insulinAUC). Total daily insulin dose per kg at 1, 3, 6 and 12 months Percentage of patients that maintain stimulated pea

Interventions

DRUGGrafalon 20 mg/ml koncentrát pro infuzní roztok

Sponsors

Institute For Clinical And Experimental Medicine, University Hospital Kralovske Vinohrady
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
AUC0-2h for a mixed meal tolerance test (MMTT) stimulated C-peptide concentration-time curve (C-peptideAUC) at 12 months relative to baseline

Secondary

MeasureTime frame
Peak MMTT stimulated C-peptide concentration (C-peptidemax) at months 6, 12 and 24 relative to baseline Change in fasting C-peptide from baseline to months 6 and 12 Change in HbA1c from baseline to month 12 HbA1c at 12 and 24 months Change in fasting plasma glucose from baseline to month 12 Total insulin treatment administered over the period of 12 months calculated as AUC (insulinAUC). Total daily insulin dose per kg at 1, 3, 6 and 12 months Percentage of patients that maintain stimulated pea

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026