Summary
Fenofibrate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Type 2 Diabetes would be drug repurposing rather than first-in-human development. This does not mean it is approved for Type 2 Diabetes. ClinicalTrials.gov lists 8 registered trials linking Fenofibrate to Type 2 Diabetes: 3 have completed; 5 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02314533). The largest enrolment is 1000 participants (NCT00261352). Registration activity spans 2002 to 2022. The literature layer holds 11 publications for this pair: 3 Cochrane reviews, 2 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2009 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Type 2 Diabetes Mellitus ranks 767 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 1.6-1.7% at 7 years on standard care (population-level cohorts UK and US).
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 68.0 (trials 18.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 3 completed, 5 other |
| Linked publications | 11 (5 clinical trial publications, 3 Cochrane reviews, 2 meta-analyses, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT02314533 | Evaluate the Efficacy of Fenofibrate on Microalbuminuria 2014 | status unknown | Phase 4 | 200 |
| NCT00261352 | GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate 2005 | terminated | Phase 3 | 1,000 |
| NCT04882293 | Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP. 2022 | status unknown | Phase 3 | 78 |
| NCT00309712 | Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study 2002 | completed | Not applicable | 300 |
| NCT05542147 | Genetic-Dependent Cardiovascular Response to PPAR-Alpha Agonist Fenofibrate 2022 | completed | Not applicable | 200 |
| NCT00349128 | Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes 2004 | completed | PHASE2, PHASE3 | 382 |
| NCT01101204 | The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines 2012 | status unknown | Not applicable | 200 |
| NCT02079376 | The DIAMOND® for the Treatment of Type 2 Diabetes 2013 | status unknown | Not applicable | 45 |
Published literature
- Clinical trial publication Chronic complication risk and benefits of fenofibrate in type 2 diabetes by a PPARα polymorphism (rs6008845, C/T): a FIELD trial substudyJanuszewski AS, Huang MLH, Mangani AS et al. · Diabetes research and clinical practice · 2026 · PMID 41730506
- Clinical trial publication Association of fenofibrate therapy with cardiovascular events and mortality in diabetes patients with early-diagnosed hyperlipidemiaLiu H, Wang K, Ren Y et al. · Lipids in health and disease · 2026 · PMID 41622209
- Clinical trial publication Alternate-day alternating monotherapy (q48h) versus daily concomitant atorvastatin-fenofibrate in adults with type 2 diabetes and mixed dyslipidemia: a 12-week randomized non-inferiority trialShahramirad S, Rezvani M, Jahanbazi R et al. · BMC endocrine disorders · 2026 · PMID 41495681
- Clinical trial publication The association of haptoglobin levels and phenotype with cardiovascular disease in Type 2 diabetes: a Fenofibrate Intervention and Event Lowering in Diabetes sub-studyOng KL, Januszewski AS, Francis H et al. · European journal of preventive cardiology · 2026 · PMID 40971905
- Meta-analysis Incidence, Progression and Determinants of Diabetic Retinopathy in Type 2 Diabetes in Australasia: A Systematic Review and Meta-AnalysisMersha GA, Molla MD, Chakraborty R et al. · Clinical & experimental ophthalmology · 2026 · PMID 41787767
- Clinical trial publication Cost-effectiveness of fenofibrate versus standard care for reducing the progression of diabetic retinopathy: An economic evaluation based on data from the LENS trialScotland G, Tsehaye M, Styles C et al. · Diabetic medicine : a journal of the British Diabetic Association · 2025 · PMID 40607724
- Cochrane review Fenofibrate for diabetic retinopathyKataoka SY, Lois N, Kawano S et al. · The Cochrane database of systematic reviews · 2023 · PMID 37310870
- Systematic review A Systematic Review of Cost-Effectiveness of Non-Statin Lipid-Lowering Drugs for Primary and Secondary Prevention of Cardiovascular Disease in Patients with Type 2 Diabetes MellitusAbushanab D, Al-Badriyeh D, Marquina C et al. · Current problems in cardiology · 2023 · PMID 35460688
- Cochrane review Novel Therapies for Kidney Disease in People With DiabetesKhurana N, James S, Coughlan MT et al. · The Journal of clinical endocrinology and metabolism · 2022 · PMID 34460928
- Cochrane review Inflammatory Activities in Type 2 Diabetes Patients With Co-morbid Angiopathies and Exploring Beneficial Interventions: A Systematic ReviewNwadiugwu MC · Frontiers in public health · 2020 · PMID 33569370
- Meta-analysis How can we improve the management of vascular risk in type 2 diabetes: insights from FIELDSteiner G · Cardiovascular drugs and therapy · 2009 · PMID 19757004
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Fenofibrate approved for Type 2 Diabetes?
Fenofibrate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Type 2 Diabetes would be drug repurposing rather than first-in-human development. This does not mean it is approved for Type 2 Diabetes. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Fenofibrate in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Fenofibrate to Type 2 Diabetes: 3 have completed; 5 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02314533). The largest enrolment is 1000 participants (NCT00261352). Registration activity spans 2002 to 2022.
What does the evidence show for Fenofibrate in Type 2 Diabetes?
Fenofibrate has both completed registered trials and synthesis-level publications linked to Type 2 Diabetes. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.