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Randomized, double-blind, multicenter, parallel group, placebo-controlled study to evaluate the efficacy and safety of phenofibrate treatment on the functions of beta cells in children and adolescents with newly diagnosed of type 1 diabetes

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517483-34-00
Acronym
PRIFEN-01
Enrollment
98
Registered
2024-09-22
Start date
2022-09-21
Completion date
Unknown
Last updated
2025-06-10

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

Conditions

Evaluation of the effect of phenofibrate on the functions of beta cells in children with new diagnosis of type 1 diabetes

Brief summary

Assessment of pancreatic beta cell function by comparing the AUC area under the curve in the C-peptide stimulation test: Change in the mean insulin secretion measured based on the C-peptide area under the curve in the stimulation test at individual time points in the compared groups of patients

Detailed description

• Fasting c-peptide concentration and maximum c-peptide concentration in the stimulation test, • Parameters of diabetes control and glucose fluctuations (including HbA1c, mean blood glucose with standard deviation, variability index, time spent in normoglycemia), • Daily and basic insulin requirements • Inflammation markers • Safety and tolerance of the fenofibrate

Interventions

DRUGPlacebo
DRUGGrofibrat S
DRUG160 mg

Sponsors

Medical University Of Warsaw
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Assessment of pancreatic beta cell function by comparing the AUC area under the curve in the C-peptide stimulation test: Change in the mean insulin secretion measured based on the C-peptide area under the curve in the stimulation test at individual time points in the compared groups of patients

Secondary

MeasureTime frame
• Fasting c-peptide concentration and maximum c-peptide concentration in the stimulation test, • Parameters of diabetes control and glucose fluctuations (including HbA1c, mean blood glucose with standard deviation, variability index, time spent in normoglycemia), • Daily and basic insulin requirements • Inflammation markers • Safety and tolerance of the fenofibrate

Countries

Poland

Outcome results

None listed

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