Summary
Glimepiride 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trials linking Glimepiride to Type 2 Diabetes: 1 is active or not yet recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02301806). The largest enrolment is 2800 participants (NCT07589387). Registration activity spans 2008 to 2026. The literature layer holds 10 publications for this pair: 5 Cochrane reviews and 5 clinical trial publications. Publication years run from 2022 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 | 78.0 (trials 28.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 6 completed, 1 other |
| Linked publications | 10 (5 Cochrane reviews, 5 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00941161 | Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus 2009 | completed | Phase 4 | 28 |
| NCT02301806 | Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM 2015 | status unknown | Phase 4 | 30 |
| NCT01087502 | Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment 2010 | completed | Phase 3 | 241 |
| NCT00622284 | Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes 2008 | completed | Phase 3 | 1,560 |
| NCT01958671 | A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO) 2013 | completed | Phase 3 | 461 |
| NCT00775684 | Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass 2008 | completed | Not applicable | 47 |
| NCT00747383 | How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin. 2008 | completed | Not applicable | 74 |
| NCT07589387 | Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3 2026 | not yet recruiting | Not applicable | 2,800 |
Published literature
- Clinical trial publication Dulaglutide versus empagliflozin as add-on therapy to metformin and sulfonylurea in type 2 diabetes: a randomized pilot study with exploratory metabolomic and microbiome analysesJun JE, Oh DH, Jeong IK et al. · Frontiers in endocrinology · 2026 · PMID 42388875
- Clinical trial publication Sodium-glucose cotransporter 2 inhibition and injection burden in mild diabetic macular edema: An exploratory post hoc analysis of the COMET trialTakatsuna Y, Ishibashi R, Koshizaka M et al. · Journal of diabetes investigation · 2026 · PMID 42089819
- Clinical trial publication Sitagliptin, Metformin and Glimepiride Fixed-Dose Combination Compared to Co-Administration of Metformin and High-Dose Glimepiride in Indian Patients With Type 2 Diabetes: A Randomised, Double-Blind, Double-Dummy, Phase 3 Clinical StudySahay R, Gowda A, Singh MK et al. · Diabetes, obesity & metabolism · 2026 · PMID 42070788
- Clinical trial publication Efficacy and Safety of Glimepiride, Voglibose, and Metformin ER in Type 2 Diabetes: A Randomized, Active-Controlled StudyMohan B, Kumar SV, Kurmi PH et al. · Journal of diabetes · 2026 · PMID 41979234
- Clinical trial publication Comparison of the Continuous Glucose Monitoring Profiles of Four Glucose-Lowering Medications in the GRADE Randomized TrialBergenstal RM, Crandall JP, Rosin SP et al. · Diabetes care · 2026 · PMID 41925680
- Cochrane review Evaluation of three mechanisms of action (SGLT2 inhibitors, GLP-1 receptor agonists, and sulfonylureas) in treating type 2 diabetes with heart failure: a systematic review and network meta-analysis of RCTsGao H, Wei Q, Zou A et al. · Frontiers in endocrinology · 2025 · PMID 40556828
- Cochrane review Effects of different hypoglycaemic drugs on beta-cell function in type 2 diabetes mellitus: a systematic review and network meta-analysisGuo Z, Huang L, Jiang Z et al. · European journal of medical research · 2025 · PMID 39985051
- Cochrane review Long-term effects of different hypoglycemic drugs on carotid intima-media thickness progression: a systematic review and network meta-analysisLv Q, Yang Y, Lv Y et al. · Frontiers in endocrinology · 2024 · PMID 38883606
- Cochrane review Comparative effectiveness of multiple different treatment regimens for nonalcoholic fatty liver disease with type 2 diabetes mellitus: a systematic review and Bayesian network meta-analysis of randomised controlled trialsDeng M, Wen Y, Yan J et al. · BMC medicine · 2023 · PMID 37974258
- Cochrane review Systematic review and meta-analysis of head-to-head trials comparing sulfonylureas and low hypoglycaemic risk antidiabetic drugsVolke V, Katus U, Johannson A et al. · BMC endocrine disorders · 2022 · PMID 36261824
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 Glimepiride approved for Type 2 Diabetes?
Glimepiride 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 Glimepiride in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Glimepiride to Type 2 Diabetes: 1 is active or not yet recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02301806). The largest enrolment is 2800 participants (NCT07589387). Registration activity spans 2008 to 2026.
What does the evidence show for Glimepiride in Type 2 Diabetes?
Glimepiride 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.