Summary
Omega-3-Acid Ethyl Esters 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lists 8 registered trials linking Omega-3-Acid Ethyl Esters to Type 2 Diabetes: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04562467). The largest enrolment is 22220 participants (NCT01633177). Registration activity spans 2003 to 2020. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2008 to 2009. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 52.0 (trials 28.0, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 2 (2 clinical trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT04562467 | The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk 2020 | completed | Phase 4 | 70 |
| NCT00758927 | The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients 2009 | status unknown | Phase 4 | 70 |
| NCT00069784 | The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention) 2003 | completed | Phase 3 | 12,537 |
| NCT01633177 | Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes 2011 | completed | Phase 3 | 22,220 |
| 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 |
| NCT02113163 | PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA 2014 | completed | Phase 1 | 32 |
| NCT00577590 | Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM 2003 | completed | Not applicable | 78 |
Published literature
- Clinical trial publication Atorvastatin in Factorial with Omega-3 EE90 Risk Reduction in Diabetes (AFORRD): a randomised controlled trialHolman RR, Paul S, Farmer A et al. · Diabetologia · 2009 · PMID 19002433
- Clinical trial publication Rationale, design, and baseline characteristics for a large international trial of cardiovascular disease prevention in people with dysglycemia: the ORIGIN Trial (Outcome Reduction with an Initial Glargine Intervention)Origin Trial Investigators, Gerstein H, Yusuf S et al. · American heart journal · 2008 · PMID 18082485
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 Omega-3-Acid Ethyl Esters approved for Type 2 Diabetes?
Omega-3-Acid Ethyl Esters 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 Omega-3-Acid Ethyl Esters in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Omega-3-Acid Ethyl Esters to Type 2 Diabetes: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04562467). The largest enrolment is 22220 participants (NCT01633177). Registration activity spans 2003 to 2020.
What does the evidence show for Omega-3-Acid Ethyl Esters in Type 2 Diabetes?
Omega-3-Acid Ethyl Esters has 6 completed trials and 2 linked publications for Type 2 Diabetes. Completed trials may or may not have posted results; follow the NCT links to check. 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.