Clinical Trials

Saxagliptin is supported by numerous clinical trials spanning Early Phase 1 through Phase 4, evaluating its safety and efficacy in type 2 diabetes, prediabetes, impaired glucose tolerance, and diabetic microalbuminuria. Sponsored by pharmaceutical entities such as AstraZeneca and academic centers like Brigham and Women's Hospital, these trials encompass completed, recruiting, terminated, and suspended statuses. Notable Phase 4 evaluations investigate fixed-dose combinations with dapagliflozin and urinary tubular markers in diabetic nephropathy, underscoring saxagliptin's key role in managing metabolic and renal outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02969798 RECRUITING
Diabetes Mellitus, Type 2; Impaired Glucose Tolerance (IGT); Impaired Fasting Glucose (IFG)
The University of Texas Health Science Center at San Antonio
 2014-01-01
NCT07033585 ACTIVE_NOT_RECRUITING
Type 2 Diabetes
Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair
 2026-06-15 PHASE2; PHASE3
NCT06107153 COMPLETED
Type2diabetes
University of Basrah
 2023-11-01 PHASE3
NCT01527747 SUSPENDED
Type 2 Diabetes; Hypertriglyceridemia
Oregon Health and Science University
 2012-01 PHASE4
NCT04445714 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2021-04-07 PHASE4
NCT03199053 COMPLETED
Diabetes Mellitus, Type 2
AstraZeneca
 2017-10-11 PHASE3
NCT03714594 COMPLETED
Type2 Diabetes Mellitus
University of Pisa
 2018-07-24 PHASE2
NCT04445714 Completed
Type 2 Diabetes Mellitus
AstraZeneca
 2021-04-07 Phase 4
NCT03660683 TERMINATED
Diabetes Mellitus, Type 2; Cardiovascular Diseases
Sabyasachi Sen
 2018-10-22 PHASE4
NCT02407899 COMPLETED
Diabetes Mellitus, Type 1
Second Xiangya Hospital of Central South University
 2015-03 PHASE4
NCT03608358 TERMINATED
Type 2 Diabetes Mellitus
AstraZeneca
 2019-02-27 PHASE3
NCT04521049 COMPLETED
Diabetes Mellitus, Type 2
Beni-Suef University
 2019-03-01 PHASE4
NCT02377388 COMPLETED
Platelet Aggregation During Acute Myocardial Infarction
University of Sao Paulo General Hospital
 2017-02-07 PHASE3
NCT02965443 TERMINATED
Type 2 Diabetes
University Hospital Tuebingen
 2018-02-02 PHASE4
NCT04170790 UNKNOWN
Diabetes Mellitus, Type 2; Erectile Dysfunction With Diabetes Mellitus; Drug Interaction
Ain Shams University
 2019-12-01
NCT03700801 COMPLETED
Type 2 Diabetes Mellitus
Zhujiang Hospital
 2018-10-01 PHASE4
NCT02946632 UNKNOWN
Diabetes Mellitus, Type II
Korea University Anam Hospital
 2016-12 PHASE3
NCT02285985 COMPLETED
Type 2 Diabetes Mellitus (T2DM)
Phoenix VA Health Care System
 2013-02 PHASE4
NCT02917031 COMPLETED
Type 2 Diabetes Mellitus; Heart Failure
AstraZeneca
 2017-01-10 PHASE4
NCT02597101 COMPLETED
Type 2 Diabetes Mellitus; Insulin Resistance
Nick Giannoukakis, PhD
 2015-11 PHASE2
NCT04521049 Completed
Diabetes Mellitus Type 2
Beni-Suef University
 2019-03-01 Phase 4
NCT02481479 COMPLETED
Diabetes Mellitus, Non-Insulin-Dependent; Heart Failure
Unity Health Toronto
 2015-06 PHASE4
NCT03933787 COMPLETED
Physical Activity; Sympathetic Nervous System; Secretion; Catecholamine
Eric Grouzmann
 2018-06-05 EARLY_PHASE1
NCT02613897 COMPLETED
Diabetes Mellitus, Type 2
The University of Texas Health Science Center at San Antonio
 2016-01
NCT02547935 COMPLETED
Type 2 Diabetes Mellitus, CKD and Albuminuria
AstraZeneca
 2015-09-21 PHASE2; PHASE3
NCT03138356 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2017-05-25 PHASE1
NCT02583438 UNKNOWN
Type 2 Diabetes; Obesity
Beijing Chao Yang Hospital
 2015-10 PHASE4
NCT02742233 UNKNOWN
Diabetic Foot Ulcer
Long Min,MD
 2015-11 PHASE4
NCT03199053 Completed
Diabetes Mellitus Type 2
AstraZeneca
 2017-10-11 Phase 3
NCT02024477 COMPLETED
Type 2 Diabetes
George Washington University
 2013-11 PHASE4
NCT02419612 COMPLETED
Diabetes
AstraZeneca
 2015-08-14 PHASE3
NCT01548651 TERMINATED
Impaired Glucose Tolerance
Baylor College of Medicine
 2012-02 PHASE4
NCT03169959 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2017-05-29 PHASE1
NCT02681094 COMPLETED
Type 2 Diabetes Mellitus; Inadequate Glycaemic Control
AstraZeneca
 2016-02-26 PHASE3
NCT02089438 COMPLETED
Type 2 Diabetes
Lund University
 2014-05 PHASE4
NCT02551874 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2015-10-20 PHASE3
NCT02462369 UNKNOWN
Microalbuminuria; Microalbuminuria /Creatinine Ratios ACR
The Second Hospital of Nanjing Medical University
 2015-06 PHASE4
NCT02471404 COMPLETED
Type 2 Diabetes Mellitus; Inadequate Glycaemic Control
AstraZeneca
 2015-09-21 PHASE4
NCT02104739 COMPLETED
Prediabetes; Obesity
The University of Texas Health Science Center, Houston
 2014-04 PHASE4
NCT02307695 UNKNOWN
Type 1 Diabetes
Nanjing Medical University
 2014-11 PHASE4
NCT02182895 COMPLETED
Diabetes Mellitus
Brigham and Women's Hospital
 2014-07 PHASE4
NCT01703637 UNKNOWN
Type 2 Diabetes Mellitus
Lin Liao
 2012-10
NCT01768208 UNKNOWN
Type 2 Diabetes
Shanghai Jiao Tong University School of Medicine
 2012-10 PHASE4
NCT02765204 COMPLETED
Diabetes Mellitus, Type 2
Uppsala University
 2016-03 PHASE4
NCT02605772 UNKNOWN
Type 2 Diabetes Mellitus
Fifth Affiliated Hospital, Sun Yat-Sen University
 2015-12 PHASE4
NCT02280486 COMPLETED
Type 2 Diabetes
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2015-01 PHASE4
NCT02284893 COMPLETED
Type 2 Diabetes
AstraZeneca
 2014-09-09 PHASE3
NCT02315495 COMPLETED
Type 2 Diabetes
Zilin Sun
 2015-04-03 PHASE3
NCT02022007 COMPLETED
Polycystic Ovary Syndrome; Disorder of Glucose Regulation
Woman's
 2014-03 PHASE3
NCT02304081 COMPLETED
Type2 Diabetes Mellitus
Prof. Dr. Thomas Forst
 2015-01 PHASE4
NCT02273050 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2014-12 PHASE3
NCT02239458 UNKNOWN
Cystic Fibrosis
Ram Weiss
 2015-06
NCT01434186 COMPLETED
Diabetes Mellitus, Type 2
AstraZeneca
 2012-05 PHASE3
NCT01204775 COMPLETED
Type 2 Diabetes
AstraZeneca
 2011-06 PHASE3
NCT02104804 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2014-05-07 PHASE3
NCT02243176 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2014-09 PHASE4
NCT02148978 UNKNOWN
Cystic Fibrosis
Ram Weiss
 2014-03
NCT01267448 COMPLETED
Diabetes Mellitus Type 2; Hyperglycemia
Cook County Health
 2014-09-09 PHASE4
NCT02920801 COMPLETED
Type 2 Diabetes Mellitus
Shanghai Zhongshan Hospital
 2014-12 PHASE4
NCT02462369 Unknown status
Microalbuminuria|Microalbuminuria /Creatinine Ratios ACR
The Second Hospital of Nanjing Medical University
 2015-06 Phase 4
NCT02386943 UNKNOWN
Type 2 Diabetes
Shanghai Jiao Tong University School of Medicine
 2013-12 PHASE4
NCT01782261 COMPLETED
Type 1 Diabetes
Medical University of Graz
 2012-02 PHASE2
NCT02223065 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2014-09 PHASE1
NCT01960205 UNKNOWN
Prediabetes
Shandong Provincial Hospital
 2013-08 PHASE4
NCT01521312 COMPLETED
Impaired Glucose Tolerance
Assistance Publique - Hôpitaux de Paris
 2012-09 PHASE2
NCT01646320 COMPLETED
Type 2 Diabetes
AstraZeneca
 2012-09 PHASE3
NCT01619059 COMPLETED
Type 2 Diabetes
AstraZeneca
 2012-06 PHASE3
NCT01765270 TERMINATED
Type 2 Diabetes Mellitus; Cardiovascular Disease
Duke University
 2013-03 PHASE4
NCT01608724 COMPLETED
Diabetes Mellitus, Non-Insulin-Dependent
AstraZeneca
 2012-11 PHASE4
NCT02060201 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2014-02 PHASE1
NCT01922817 COMPLETED
Type 1 Diabetes; Hypoglycaemia
University of Dundee
 2012-09 PHASE3
NCT01552018 COMPLETED
Coronary Artery Disease; Diabetes Mellitus Type 2
Oslo University Hospital
 2012-03 PHASE4
NCT01606007 COMPLETED
Type 2 Diabetes
AstraZeneca
 2012-07 PHASE3
NCT01874080 COMPLETED
Diabetes
AstraZeneca
 2013-06 PHASE1
NCT01525225 TERMINATED
Type 2 Diabetes Mellitus
AstraZeneca
 2012-09 PHASE1
NCT01107886 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2010-05 PHASE4
NCT01755494 COMPLETED
Type 2 Diabetes Mellitus(T2DM)
AstraZeneca
 2013-02 PHASE1
NCT01319357 COMPLETED
Diabetes Mellitus Type 2
University of Erlangen-Nürnberg Medical School
 2010-10 PHASE3
NCT01582308 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2012-06-21 PHASE1
NCT01660386 UNKNOWN
Type 2 Diabetes
Shanghai Jiao Tong University School of Medicine
 2012-07 PHASE4
NCT01662999 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2012-08 PHASE1
NCT01006603 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2009-10 PHASE4
NCT01441869 COMPLETED
Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin
AstraZeneca
 2011-10 PHASE1
NCT01365091 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2011-06 PHASE1
NCT01128153 COMPLETED
Type 2 Diabetes
AstraZeneca
 2010-06 PHASE3
NCT01305551 WITHDRAWN
Type 2 Diabetes
AstraZeneca
 2011-03 PHASE1
NCT01206647 UNKNOWN
Diabetes Mellitus, Type 2
ikfe-CRO GmbH
 2010-02 PHASE4
NCT01162876 COMPLETED
Diabetes
Kyowa Kirin Co., Ltd.
 2010-07 PHASE3
NCT00960076 COMPLETED
Type 2 Diabetes
AstraZeneca
 2009-08 PHASE3
NCT00918879 COMPLETED
Type 2 Diabetes
AstraZeneca
 2009-05 PHASE3
NCT00918138 COMPLETED
Type 2 Diabetes
AstraZeneca
 2009-08 PHASE3
NCT00757588 COMPLETED
Type 2 Diabetes
AstraZeneca
 2008-11 PHASE3
NCT01068717 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2010-03 PHASE1
NCT00857558 COMPLETED
Diabetes, Type 2
Kyowa Kirin Co., Ltd.
 2009-01 PHASE2
NCT01068743 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2010-02 PHASE1
NCT00885378 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2009-05 PHASE3
NCT01192139 COMPLETED
Diabetes Mellitus
AstraZeneca
 2009-11 PHASE1
NCT01192152 COMPLETED
Diabetes Mellitus
AstraZeneca
 2009-11 PHASE1
NCT00698932 COMPLETED
Type 2 Diabetes
AstraZeneca
 2008-06 PHASE3
NCT00661362 COMPLETED
Type 2 Diabetes
AstraZeneca
 2008-06 PHASE3
NCT00899470 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2009-06 PHASE1
NCT00935467 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2009-07 PHASE1
NCT00575588 COMPLETED
Type 2 Diabetes
AstraZeneca
 2007-12 PHASE3
NCT00897390 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2009-06 PHASE1
NCT00614939 COMPLETED
Type 2 Diabetes
AstraZeneca
 2008-01 PHASE3
NCT00666458 COMPLETED
Type 2 Diabetes
AstraZeneca
 2008-04 PHASE3
NCT00683657 COMPLETED
Type 2 Diabetes
AstraZeneca
 2008-07 PHASE3
NCT00770302 COMPLETED
Type 2 Diabetes
AstraZeneca
 2008-10 PHASE1
NCT00374907 COMPLETED
Type 2 Diabetes
AstraZeneca
 2006-09 PHASE3
NCT00327015 COMPLETED
Diabetes
AstraZeneca
 2006-05 PHASE3
NCT00316082 COMPLETED
Diabetes
AstraZeneca
 2006-06 PHASE3
NCT00295633 COMPLETED
Diabetes Mellitus, Type 2
AstraZeneca
 2006-03 PHASE3
NCT00313313 COMPLETED
Diabetes
AstraZeneca
 2006-04 PHASE3
NCT00121667 COMPLETED
Diabetes Mellitus, Type 2
AstraZeneca
 2005-08 PHASE3
NCT00121641 COMPLETED
Diabetes Mellitus, Type 2
AstraZeneca
 2005-07 PHASE3
NCT00950599 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2003-05 PHASE2
NCT01006590 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2009-10 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-08-27)

Check the Saxagliptin (BMS-477118) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Saxagliptin functions by selectively and reversibly binding to dipeptidyl peptidase-4 (DPP-4), thereby preventing the enzymatic degradation of endogenous incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Elevated active incretin levels enhance glucose-dependent insulin secretion from pancreatic beta cells while suppressing glucagon release, leading to improved glycemic control in clinical conditions such as type 2 diabetes mellitus.

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.