Summary
Irbesartan 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registered trials linking Irbesartan to Type 2 Diabetes: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00741585). It plans or enrolled 21983 participants. Registration activity spans 2003 to 2016. The literature layer holds 7 publications for this pair: 1 Cochrane review, 1 systematic review and 5 clinical trial publications. Publication years run from 2005 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 | A · Strong |
|---|---|
| Evidence score | 68.0 (trials 30.0, literature 18.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 6 completed, 1 other |
| Linked publications | 7 (5 clinical trial publications, 1 Cochrane review, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01588795 | Renal Denervation in Diabetic Nephropathy 2012 | completed | Phase 4 | 25 |
| NCT00741585 | Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment 2008 | completed | Phase 4 | 21,983 |
| NCT00549133 | Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol 2003 | completed | Phase 4 | 44 |
| NCT02842359 | Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension 2016 | completed | Phase 4 | 11 |
| NCT02817360 | NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients 2016 | recruiting | Phase 4 | 2,400 |
| NCT01500590 | Effect of Renin-angiotensin System Blockers on Glomerular Filtration Rate in Patients With Hypertension, Type 2 Diabetes With Normoalbuminuria 2011 | status unknown | Phase 4 | 1,400 |
| NCT00317915 | Irbesartan in Type 2 Diabetes | completed | Phase 3 | — |
| NCT01109212 | The Effects of Bindarit in Diabetic Nephropathy 2007 | completed | Phase 2 | 100 |
Published literature
- Clinical trial publication Sex differences in the efficacy of angiotensin receptor blockers on kidney and cardiovascular outcomes among individuals with type 2 diabetes and diabetic kidney disease: post hoc analyses of the RENAAL and IDNT trialsde Vries ST, Pena MJ, Tye SC et al. · Diabetologia · 2025 · PMID 39656268
- Clinical trial publication A Prospective, Multicentered, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Keluoxin Capsules in the Treatment of Microalbuminuria in Patients with Type 2 Early Diabetic Kidney DiseaseZhao J, Wang S, Li X et al. · Journal of integrative and complementary medicine · 2024 · PMID 37733303
- Clinical trial publication Efficacy of Combined Abelmoschus manihot and Irbesartan for Reduction of Albuminuria in Patients With Type 2 Diabetes and Diabetic Kidney Disease: A Multicenter Randomized Double-Blind Parallel Controlled Clinical TrialZhao J, Tostivint I, Xu L et al. · Diabetes care · 2022 · PMID 35613364
- Clinical trial publication Irbesartan treatment does not influence plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone in participants with type 2 diabetes and microalbuminuria: An IRMA2 sub-studyPiazza M, Hanssen NMJ, Persson F et al. · Diabetic medicine : a journal of the British Diabetic Association · 2021 · PMID 32961617
- Clinical trial publication Effects of Different Doses of Irbesartan Combined With Spironolactone on Urinary Albumin Excretion Rate in Elderly Patients With Early Type 2 Diabetic NephropathyChen Y, Liu P, Chen X et al. · The American journal of the medical sciences · 2018 · PMID 29753370
- Cochrane review Comprehensive overview: efficacy, tolerability, and cost-effectiveness of irbesartanGialama F, Maniadakis N · Vascular health and risk management · 2013 · PMID 24124375
- Systematic review Systematic review on urine albumin testing for early detection of diabetic complicationsNewman DJ, Mattock MB, Dawnay AB et al. · Health technology assessment (Winchester, England) · 2005 · PMID 16095545
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 Irbesartan approved for Type 2 Diabetes?
Irbesartan 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 Irbesartan in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Irbesartan to Type 2 Diabetes: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00741585). It plans or enrolled 21983 participants. Registration activity spans 2003 to 2016.
What does the evidence show for Irbesartan in Type 2 Diabetes?
Irbesartan 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.