Summary
Alogliptin Benzoate 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 7 registered trials linking Alogliptin Benzoate to Type 2 Diabetes: 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03950505). The largest enrolment is 781430 participants (NCT05220917). Registration activity spans 2014 to 2021. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2013. 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 | 42.5 (trials 20.5, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 7 total: 0 recruiting, 1 active / not yet recruiting, 5 completed, 1 other |
| Linked publications | 1 (1 clinical trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT03950505 | To Evaluate the Effect of Nesinaact on Non-alcoholic Steatohepatitis Through MRI and Liver Fibroscan in Patients With Type 2 Diabetes 2020 | status unknown | Phase 4 | 60 |
| NCT02856113 | Phase 3 Alogliptin Pediatric Study 2016 | completed | Phase 3 | 152 |
| NCT05220917 | Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study 2021 | active, not recruiting | Not applicable | 781,430 |
| NCT02798172 | The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy 2014 | completed | Not applicable | 81 |
| NCT02756832 | An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2 2016 | completed | Not applicable | 1,409 |
| NCT04980040 | A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea 2014 | completed | Not applicable | 3,623 |
| NCT04980014 | A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea 2015 | completed | Not applicable | 730 |
Published literature
- Clinical trial publication Long-term effects of alogliptin benzoate in hemodialysis patients with diabetes: a 2-year studyNakamura Y, Inagaki M, Shimizu T et al. · Nephron. Clinical practice · 2013 · PMID 23774306
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 Alogliptin Benzoate approved for Type 2 Diabetes?
Alogliptin Benzoate 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 Alogliptin Benzoate in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 7 registered trials linking Alogliptin Benzoate to Type 2 Diabetes: 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03950505). The largest enrolment is 781430 participants (NCT05220917). Registration activity spans 2014 to 2021.
What does the evidence show for Alogliptin Benzoate in Type 2 Diabetes?
Alogliptin Benzoate has 5 completed trials and 1 linked publication 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.