Summary
Omega-3 fatty acids has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. ClinicalTrials.gov lists 8 registered trials linking Omega-3 fatty acids to Type 2 Diabetes: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02422446). The largest enrolment is 490 participants (NCT02370537). Registration activity spans 2014 to 2026. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 4 clinical trial publications. Publication years run from 2020 to 2025. 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 | C · Preliminary |
|---|---|
| Evidence score | 57.5 (trials 22.5, literature 30.0, tier 5, approved bonus 0.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 15 (5 Cochrane reviews, 4 meta-analyses, 4 clinical trial publications, 1 systematic review, 1 randomised controlled trial publication) |
| Agent type | Supplement |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023 |
| Data sources | OSMF Chronic Disease Review |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02422446 | Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects 2015 | terminated | Phase 3 | 2 |
| NCT02370537 | A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI 2015 | completed | Phase 2 | 490 |
| NCT02279407 | A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients 2015 | completed | Phase 2 | 223 |
| NCT02034266 | The Effect of Omega-3 Supplementation on Nerve Structure and Function in Type 1 Diabetes 2014 | completed | Phase 2 | 40 |
| NCT07575438 | Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults 2026 | not yet recruiting | Phase 2 | 84 |
| NCT03380416 | Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients 2017 | completed | Not applicable | 49 |
| NCT07677995 | Free Fatty Acid Effects In Type 2 Diabetes 2026 | enrolling by invitation | Not applicable | 60 |
| NCT02800252 | Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics 2016 | status unknown | Not applicable | 75 |
Published literature
- Clinical trial publication Impact of omega-3 fatty acids on hypertriglyceridemia, lipidomics, and gut microbiome in patients with type 2 diabetesLu J, Liu R, Ren H et al. · Med (New York, N.Y.) · 2025 · PMID 39163858
- Cochrane review The Impact of Antioxidant Adjuncts on Periodontal Health in Type 2 Diabetes Patients: A Meta-AnalysisAbdulla SA, Abdalla BA, Muhammed AA et al. · Clinical and experimental dental research · 2025 · PMID 41158097
- Meta-analysis Dose-dependent effects of omega-3 polyunsaturated fatty acids on C-reactive protein concentrations in cardiometabolic disorders: a dose-response meta-analysis of randomized clinical trialsAmlashi MA, Payahoo A, Maskouni SJ et al. · Inflammopharmacology · 2025 · PMID 40263171
- Meta-analysis Vitamin D supplementation vs. placebo and incident type 2 diabetes in an ancillary study of the randomized Vitamin D and Omega-3 TrialTobias DK, Pradhan AD, Duran EK et al. · Nature communications · 2025 · PMID 40199888
- Clinical trial publication Improvement in Glycolipid Metabolism Parameters After Supplementing Fish Oil-Derived Omega-3 Fatty Acids Is Associated with Gut Microbiota and Lipid Metabolites in Type 2 Diabetes MellitusXia J, Yin S, Yu J et al. · Nutrients · 2024 · PMID 39519588
- Clinical trial publication EPA and DHA inhibit LDL-induced upregulation of human adipose tissue NLRP3 inflammasome/IL-1β pathway and its association with diabetes risk factorsLamantia V, Bissonnette S, Beaudry M et al. · Scientific reports · 2024 · PMID 39511203
- Clinical trial publication Biomarkers of glucose-insulin homeostasis and incident type 2 diabetes and cardiovascular disease: results from the Vitamin D and Omega-3 trialQian F, Guo Y, Li C et al. · Cardiovascular diabetology · 2024 · PMID 39488682
- Meta-analysis The effects of ω-3 fatty acids on inflammatory and oxidative stress markers in patients with Type 2 diabetes mellitus: A systematic review and meta-analysis of controlled trialsMuzammil K, Khaleel AQ, Merza MS et al. · Prostaglandins & other lipid mediators · 2024 · PMID 39243880
- Randomized controlled trial The effect of curcumin and high-content eicosapentaenoic acid supplementations in type 2 diabetes mellitus patients: a double-blinded randomized clinical trialAsghari KM, Saleh P, Salekzamani Y et al. · Nutrition & diabetes · 2024 · PMID 38589346
- Cochrane review Can omega-3 fatty acids and vitamin E co-supplementation affect obesity indices?Musazadeh V, Tandorost A, Zarezadeh M et al. · International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition · 2023 · PMID 35796416
- Cochrane review Could nutrient supplements provide additional glycemic control in diabetes management? A systematic review and meta-analysis of randomized controlled trials of as an add-on nutritional supplementation therapyKim Y, Oh YK, Lee J et al. · Archives of pharmacal research · 2022 · PMID 35304727
- 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
- Meta-analysis Omega-3 polyunsaturated fatty acid biomarkers and risk of type 2 diabetes, cardiovascular disease, cancer, and mortalityJiang H, Wang L, Wang D et al. · Clinical nutrition (Edinburgh, Scotland) · 2022 · PMID 35830775
- Systematic review The effects of omega-3 fatty acids in type 2 diabetes: A systematic review and meta-analysisXiao Y, Zhang Q, Liao X et al. · Prostaglandins, leukotrienes, and essential fatty acids · 2022 · PMID 35717726
- Cochrane review Effects of fish oil supplementation on glucose control and lipid levels among patients with type 2 diabetes mellitus: a Meta-analysis of randomized controlled trialsGao C, Liu Y, Gan Y et al. · Lipids in health and disease · 2020 · PMID 32384902
Mechanism and notes
Recorded mechanism or class: Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Omega-3 fatty acids approved for Type 2 Diabetes?
Omega-3 fatty acids has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Omega-3 fatty acids in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Omega-3 fatty acids to Type 2 Diabetes: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02422446). The largest enrolment is 490 participants (NCT02370537). Registration activity spans 2014 to 2026.
What does the evidence show for Omega-3 fatty acids in Type 2 Diabetes?
Omega-3 fatty acids 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 C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. 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.