Clinical Trials
Numerous clinical trials evaluate acarbose across metabolic, cardiovascular, and oncological indications, primarily focusing on type 2 diabetes mellitus alongside studies in kidney cancer, aging, Pompe's disease, and endothelial dysfunction. Spanning Phase 1 through Phase 4, these protocols are supported by academic institutions such as the University of Alabama at Birmingham and Montefiore Medical Center, as well as industry sponsors including Bayer and Boehringer Ingelheim. Recruitment statuses encompass completed, active non-recruiting, and upcoming trials, including evaluations of combination regimens for metastatic renal cell carcinoma.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07074379 | RECRUITING | Painless Chronic Pancreatitis |
Changhai Hospital |
2025-07-21 | |
| NCT07122102 | NOT_YET_RECRUITING | Type 2 Diabetes |
Haisco Pharmaceutical Group Co., Ltd. |
2025-10-01 | |
| NCT07711171 | RECRUITING | Type 2 Diabetes Mellitus; Cognitive Impairment |
Fudan University |
2024-08-19 | PHASE4 |
| NCT05487859 | WITHDRAWN | Kidney Cancer |
University of Alabama at Birmingham |
2025-12-31 | PHASE2 |
| NCT07436585 | COMPLETED | Diabetes; Diabetes Complications; Diabetic Neuropathy |
Shifa International Hospital |
2025-09-01 | PHASE1 |
| NCT05487859 | Not yet recruiting | Kidney Cancer |
University of Alabama at Birmingham |
2025-10-05 | Phase 2 |
| NCT06993428 | NOT_YET_RECRUITING | Overweight or Obese; Obesity and Overweight |
Empros Pharma AB |
2025-05-20 | PHASE2 |
| NCT05934110 | UNKNOWN | Overweight or Obesity |
Empros Pharma AB |
2023-04-18 | PHASE2 |
| NCT05261997 | UNKNOWN | Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency; Abdominal Pain; Cholangiopancreatography, Endoscopic Retrograde |
Changhai Hospital |
2022-03 | |
| NCT03380546 | TERMINATED | Gestational Diabetes Mellitus in Pregnancy |
Assistance Publique - Hôpitaux de Paris |
2018-07-04 | PHASE3 |
| NCT05629806 | UNKNOWN | Type 2 Diabetes; Blood Glucose Fluctuation |
Nanjing First Hospital, Nanjing Medical University |
2022-04-10 | PHASE3 |
| NCT02589353 | COMPLETED | Healthy Volunteers |
Oregon State University |
2017-04-21 | PHASE4 |
| NCT05542849 | COMPLETED | Tolerance; Side Effect; Glucose Response |
AgelessRx |
2022-08-10 | PHASE4 |
| NCT04521751 | COMPLETED | Overweight or Obesity |
Empros Pharma AB |
2020-05-07 | PHASE1; PHASE2 |
| NCT01019356 | COMPLETED | Polycystic Ovary Syndrome |
Jean-Patrice Baillargeon |
2006-08 | |
| NCT01914133 | COMPLETED | Other Specified Hypotension; Syncope |
Kenneth Madden |
2014-01 | PHASE2 |
| NCT05035849 | COMPLETED | Type 2 Diabetes |
Nanjing First Hospital, Nanjing Medical University |
2020-01-30 | |
| NCT04287387 | UNKNOWN | Type2 Diabetes Mellitus |
Peking Union Medical College Hospital |
2020-03-02 | PHASE4 |
| NCT03794336 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2019-06-29 | PHASE4 |
| NCT04665570 | Active not recruiting | Type 2 Diabetes Mellitus |
Bayer |
2020-12-21 | -- |
| NCT03961659 | UNKNOWN | Type 2 Diabetes Mellitus; Obesity; Cognitive Impairment |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
2019-05 | |
| NCT03359837 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2018-01-20 | PHASE4 |
| NCT04180813 | Terminated | Diabetes Mellitus Type 2 |
Boehringer Ingelheim |
2020-03-04 | -- |
| NCT04065581 | COMPLETED | Diabetes Mellitus, Type 2 |
Bayer |
2019-10-14 | PHASE1 |
| NCT03349684 | COMPLETED | Diabetes Mellitus, Type 2 |
Bayer |
2018-03-05 | PHASE3 |
| NCT02685852 | COMPLETED | Hyperinsulinemic Hypoglycemia |
University of Minnesota |
2016-02 | PHASE1 |
| NCT03344341 | TERMINATED | Type 2 Diabetes Mellitus |
AstraZeneca |
2017-12-15 | PHASE4 |
| NCT03602638 | UNKNOWN | Atherosclerosis Type 2 Diabetes Mellitus Dipeptidyl Peptidase-4 Inhibitor GLP-1 |
Chinese PLA General Hospital |
2018-10-01 | PHASE4 |
| NCT02953093 | TERMINATED | Aging |
Montefiore Medical Center |
2017-08-30 | PHASE2 |
| NCT03383068 | UNKNOWN | PCOS; Impaired Glucose Tolerance |
RenJi Hospital |
2018-01-01 | PHASE4 |
| NCT02836704 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2016-09-09 | PHASE4 |
| NCT03241303 | COMPLETED | Glucose Metabolism Disorders |
University Hospital, Gentofte, Copenhagen |
2017-08-01 | |
| NCT02999841 | UNKNOWN | Diabetes Mellitus, Type 2; Obesity |
Peking University |
2016-03 | PHASE4 |
| NCT02446834 | COMPLETED | Polycystic Ovary Syndrome |
RenJi Hospital |
2015-04 | |
| NCT02865499 | COMPLETED | Aging |
The University of Texas Health Science Center at San Antonio |
2016-06 | PHASE2 |
| NCT02953093 | Completed | Aging |
Montefiore Medical Center |
2017-08-30 | Phase 2 |
| NCT02879955 | COMPLETED | Overweight |
Hvidovre University Hospital |
2016-08 | |
| NCT00829660 | COMPLETED | Coronary Heart Disease; Acute Coronary Syndrome; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus (T2DM) |
University of Oxford |
2009-02-17 | PHASE4 |
| NCT02527993 | COMPLETED | Hypoglycemia; Obesity; Surgery |
Zealand University Hospital |
2015-10 | PHASE4 |
| NCT02462369 | UNKNOWN | Microalbuminuria; Microalbuminuria /Creatinine Ratios ACR |
The Second Hospital of Nanjing Medical University |
2015-06 | PHASE4 |
| NCT02589353 | Completed | Healthy Volunteers |
Oregon State University |
2017-04-21 | Phase 4 |
| NCT00223691 | COMPLETED | Autonomic Failure; Orthostatic Hypotension |
Vanderbilt University |
2002-03 | PHASE1 |
| NCT02605772 | UNKNOWN | Type 2 Diabetes Mellitus |
Fifth Affiliated Hospital, Sun Yat-Sen University |
2015-12 | PHASE4 |
| NCT02438397 | UNKNOWN | Type 2 Diabetes |
Shanghai 6th People's Hospital |
2014-12 | PHASE4 |
| NCT02315495 | COMPLETED | Type 2 Diabetes |
Zilin Sun |
2015-04-03 | PHASE3 |
| NCT02049814 | COMPLETED | Type 2 Diabetes Mellitus |
Takeda |
2014-05-09 | PHASE4 |
| NCT02143765 | COMPLETED | Type 2 Diabetes Mellitus |
Zhongda Hospital |
2014-05 | PHASE4 |
| NCT02500329 | UNKNOWN | Endothelial Function; Type 2 Diabetes; Gemigliptin; Acarbose |
Seoul National University Hospital |
2014-09 | PHASE4 |
| NCT02072096 | TERMINATED | Diabetes Mellitus, Type 2 |
Eli Lilly and Company |
2014-02 | PHASE4 |
| NCT02243176 | COMPLETED | Type 2 Diabetes Mellitus |
AstraZeneca |
2014-09 | PHASE4 |
| NCT02527239 | Unknown status | Pompe''s Disease |
Royal Brompton & Harefield NHS Foundation Trust|Genzyme a Sanofi Company |
2015-09 | -- |
| NCT01863147 | COMPLETED | Newly Diagnosed Type 2 Diabetes; Coronary Artery Disease |
Wuhan General Hospital of Guangzhou Military Command |
2013-07 | PHASE4 |
| NCT01709305 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2012-11-08 | PHASE4 |
| NCT01181674 | COMPLETED | Type 2 Diabetes Mellitus |
Population Health Research Institute |
2011-01 | PHASE4 |
| NCT01490918 | COMPLETED | Type 2 Diabetes Mellitus |
The Catholic University of Korea |
2012-04 | PHASE4 |
| NCT02355509 | COMPLETED | Glucose Intolerance; Postprandial Hyperglycemia; Cardiovascular Risk Factor |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
2010-01 | PHASE4 |
| NCT01839344 | COMPLETED | Diabetes Mellitus, Type 2 |
Bastyr University |
2013-05 | PHASE2 |
| NCT01758471 | UNKNOWN | Type 2 Diabetes |
Shanghai Jiao Tong University School of Medicine |
2012-12 | PHASE4 |
| NCT01177384 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2011-01-25 | PHASE3 |
| NCT01316861 | COMPLETED | Type 2 Diabetes Mellitus |
EMS |
2012-09 | PHASE3 |
| NCT02043886 | COMPLETED | Type 2 Diabetes; Postprandial Hypotension |
University of British Columbia |
2007-06 | PHASE2 |
| NCT01025765 | UNKNOWN | Chronic Hepatitis C |
National Taiwan University Hospital |
2009-11 | PHASE4 |
| NCT01175486 | UNKNOWN | Diabetes |
Taipei Veterans General Hospital, Taiwan |
2010-07 | PHASE4 |
| NCT01728740 | COMPLETED | Diabetes Mellitus, Type II |
Bayer |
2012-09 | PHASE1 |
| NCT01514838 | TERMINATED | Type II Diabetes Mellitus |
Astellas Pharma Inc |
2012-04-23 | PHASE3 |
| NCT01554631 | COMPLETED | Diabetes Mellitus, Type 2 |
Bayer |
2012-03 | PHASE1 |
| NCT00970528 | COMPLETED | Diabetes Mellitus, Type 2 |
Bayer |
2009-11 | PHASE4 |
| NCT00858676 | UNKNOWN | Diabetes Mellitus; Impaired Glucose Tolerance; Coronary Artery Disease |
Aichi Gakuin University |
2009-04 | PHASE4 |
| NCT01624116 | COMPLETED | Diabetes, Type 2 |
Services Hospital, Lahore |
2011-08 | |
| NCT01388153 | COMPLETED | Diabetes Mellitus, Type 2 |
Bayer |
2011-06 | PHASE1 |
| NCT01245166 | UNKNOWN | The Objectives of the Study is to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg; Plus Acarbose 50 mg Tablets) Thrice Daily Versus Acarbose 50 mg Thrice Daily Over 16 Weeks in; Subjects With Type 2 Diabetes Mellitus. |
Lotus Pharmaceutical |
2010-11 | PHASE3 |
| NCT01030952 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2009-12 | PHASE4 |
| NCT01000688 | COMPLETED | Type 2 Diabetes; Endothelial Dysfunction |
Radboud University Medical Center |
2010-01 | PHASE3 |
| NCT00928889 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2009-07 | PHASE4 |
| NCT00417729 | COMPLETED | Diabetes Mellitus |
Taichung Veterans General Hospital |
2007-01 | PHASE4 |
| NCT01279512 | COMPLETED | PCO |
Royan Institute |
2006-12 | PHASE4 |
| NCT02211950 | COMPLETED | Healthy |
Boehringer Ingelheim |
2008-10 | PHASE1 |
| NCT00846521 | TERMINATED | Pediatric Obesity; Insulin Resistance; Impaired Glucose Tolerance; Cardiovascular Disease |
Yale University |
2006-09 | PHASE4 |
| NCT00677521 | TERMINATED | Non-alcoholic Fatty Liver Disease |
The Hospital for Sick Children |
2007-01 | PHASE2 |
| NCT00437918 | COMPLETED | Diabetes Mellitus; Type 2 Diabetes Mellitus |
Inje University |
2007-01 | PHASE4 |
| NCT00551954 | COMPLETED | Type 2 Diabetes |
Technische Universität Dresden |
2006-07 | PHASE3 |
| NCT01010100 | COMPLETED | Diabetes Mellitus |
Bayer |
2000-08 | PHASE3 |
| NCT00110240 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2005-04 | PHASE3 |
| NCT01470937 | COMPLETED | Type 2 Diabetes Mellitus |
Indiana University |
1998-02 | PHASE4 |
| NCT01244971 | COMPLETED | Diabetes Mellitus Type 2 |
Karolinska Institutet |
2004-01 | PHASE4 |
| NCT00417950 | UNKNOWN | Diabetes Mellitus; Impaired Glucose Tolerance |
Taichung Veterans General Hospital |
2007-01 | |
| NCT00464594 | UNKNOWN | Diabetes Mellitus |
Japan Early Diabetes Intervention Study Group |
2007-04 | |
| NCT00558883 | COMPLETED | Type 2 Diabetes Mellitus; Subclinical Inflammation |
GWT-TUD GmbH |
2005-01 | PHASE3 |
| NCT00221156 | COMPLETED | Glucose Metabolism Disorders; Coronary Artery Disease |
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
2005-05 | PHASE3 |
| NCT00629213 | COMPLETED | Metabolic Syndrome |
GWT-TUD GmbH |
PHASE3 |
(data from https://clinicaltrials.gov, updated on 2025-08-06)
Check the
Acarbose
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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Note: Technical data last updated: Sep 1, 2026.