Summary
Acarbose 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 Acarbose to Type 2 Diabetes: 8 have completed. The most advanced is Phase 4 (NCT03794336). The largest enrolment is 3310 participants (NCT01167231). Registration activity spans 2007 to 2020. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 3 meta-analyses 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 | 80.0 (trials 30.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 8 completed, 0 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00970528 | Glucose Reduction by Early Acarbose Treatment in Basal Insulin 2009 | completed | Phase 4 | 124 |
| NCT03794336 | Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive 2019 | completed | Phase 4 | 1,293 |
| NCT01316861 | Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus 2012 | completed | Phase 3 | 79 |
| NCT03349684 | Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients 2018 | completed | Phase 3 | 287 |
| NCT01697592 | Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015) 2012 | completed | Phase 3 | 585 |
| NCT01388153 | A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet 2011 | completed | Phase 1 | 33 |
| NCT01167231 | Prevention of Postprandial Hyperglycemia by Acarbose May be a Promising Therapeutic Strategy for Reducing the Increased Risk for Cardiovascular Disease 2007 | completed | Not applicable | 3,310 |
| NCT05035849 | Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose 2020 | completed | Not applicable | 60 |
Published literature
- Meta-analysis Probiotics, synbiotics and berberine in Type 2 diabetes mellitus: A systematic review, meta-analysis, and molecular dynamics simulation studyShadin M, Bhuia MS, Alfaifi M et al. · PloS one · 2026 · PMID 42213651
- Clinical trial publication Dapagliflozin restores odour-induced functional integration of primary olfactory cortex circuit but not olfactory-related regional brain activation in patients with type 2 diabetes: A 16-week randomised comparative studyLi X, Zhang Y, Bi Y et al. · Diabetes, obesity & metabolism · 2025 · PMID 40954925
- Clinical trial publication Effect of acarbose and vildagliptin on plasma trimethylamine N-oxide levels in patients with type 2 diabetes mellitus: a 6-month, two-arm randomized controlled trialYang X, Zhang X, Sun C et al. · Frontiers in endocrinology · 2025 · PMID 40395816
- Clinical trial publication Baseline glucagon impacts glucose-lowering effects of acarbose but not metformin: A sub-analysis of MARCH studyJiang L, Zhou L, Liu J et al. · Diabetes research and clinical practice · 2025 · PMID 40319921
- Clinical trial publication Comparison of glucose fluctuation between metformin combined with acarbose or sitagliptin in Chinese patients with type 2 diabetes: A multicenter, randomized, active-controlled, open-label, parallel design clinical trialCai X, Hu S, Lin C et al. · Chinese medical journal · 2025 · PMID 40178116
- Clinical trial publication Effects of acarbose and metformin on thyroid function and thyroid hormone sensitivity in type 2 diabetes patients: a post-hoc analysis of the MARCH studyZhang C, Liu A, Teng W et al. · Journal of endocrinological investigation · 2025 · PMID 39400888
- 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
- Meta-analysis α-Glucosidase-targeting 1,2,4-triazole antidiabetic candidates: comparative analysis and future perspectivesAbulkhair HS · Future medicinal chemistry · 2025 · PMID 41250931
- Meta-analysis Emodin, a rising star in the treatment of glycolipid metabolism disorders: a preclinical systematic review and meta-analysisXiao Y, Zhao Z, Chen B et al. · PeerJ · 2025 · PMID 40386230
- Cochrane review Evaluation of glucose-lowering medications in older people: a comprehensive systematic review and network meta-analysis of randomized controlled trialsPan SY, Su EL, Huang CJ et al. · Age and ageing · 2024 · PMID 39137064
- 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 Associations of antidiabetic drugs with diabetic retinopathy in people with type 2 diabetes: an umbrella review and meta-analysisTan L, Wang Z, Okoth K et al. · Frontiers in endocrinology · 2023 · PMID 38239984
- Cochrane review All-cause mortality and cardiovascular events in patients with type 2 diabetes treated with alpha-glucosidase inhibitors: A meta-analysis of randomized controlled trialsMannucci E, Gallo M, Pintaudi B et al. · Nutrition, metabolism, and cardiovascular diseases : NMCD · 2022 · PMID 34893404
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 Acarbose approved for Type 2 Diabetes?
Acarbose 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 Acarbose in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Acarbose to Type 2 Diabetes: 8 have completed. The most advanced is Phase 4 (NCT03794336). The largest enrolment is 3310 participants (NCT01167231). Registration activity spans 2007 to 2020.
What does the evidence show for Acarbose in Type 2 Diabetes?
Acarbose 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.