Effect of fenofibrate on residual beta cell function in adults and adolescents with newly diagnosed type 1 diabetes: a randomised clinical trial
Authors' conclusion
Contrary to the beneficial effects of fenofibrate found in preclinical studies, this longitudinal, randomised, placebo-controlled trial does not support the use of fenofibrate for preserving beta cell function in individuals with newly diagnosed type 1 diabetes.
Study context
- Population
- Individuals aged 16 to 40 years with newly diagnosed T1D56 analysed
- Participants
- 58 individuals
- Comparison
- Fenofibrate 160 mg daily oral vs placebo for 52 weeks
- Fenofibraten = 27
- Placebon = 29reference
- Primary endpoint
- Change in beta cell function: AUC for C-peptide following a 2 h mixed-meal tolerance test
- Follow-up
- 52 weeks
Methodological detailsphase 2, placebo-controlled, double-blinded, block randomisation (block size 4, 1:1), Blinding maintained for participants, healthcare providers and outcome staff, Follow-up in vitro experiments in human islets showed a stress-inducing effect of fenofibrate
- Phase 2
- Placebo-controlled
- Double-blinded
- Block randomisation (block size 4, 1:1)
- Blinding maintained for participants, healthcare providers and outcome staff
- Follow-up in vitro experiments in human islets showed a stress-inducing effect of fenofibrate
Primary result
2 h C-peptide
Mean difference
0.08 nmol/l
95% CI −0.05 to 0.23
Between Fenofibrate and Placebo
mean difference 0.08 nmol/l (95% CI −0.05 to 0.23)
As reported in the abstract
Secondary outcomes
| Outcome | Mean difference (95% CI) | P value | |
|---|---|---|---|
| PI/C ratio · week 52 | 0.024 (0.000–0.048) | P < 0.05 | |
| −0.0200.020.040.06Difference (linear scale) |
Insulin use and glycaemic control · 52 weeks
- No significant differences between groups in insulin use or glycaemic control
Blood lipidome · week 52
- Fenofibrate repressed pathways in sphingolipid metabolism and signalling vs placebo
Safety
Adverse events · 52 weeks
- Serious adverse events
- 0
- Few adverse events
Original publication
Effect of fenofibrate on residual beta cell function in adults and adolescents with newly diagnosed type 1 diabetes: a randomised clinical trial. Diabetologia. Published 30 October 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →