NCT04542291 is a Phase 1 clinical trial of Dapagliflozin in Pancreas Cancer, sponsored by Washington University School of Medicine.

Who is sponsoring NCT04542291?

NCT04542291 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT04542291?

Interventions in NCT04542291: Dapagliflozin, BIOSENSE meters.

What condition does NCT04542291 study?

NCT04542291 studies Pancreas Cancer, Pancreatic Cancer, Cancer of the Pancreas.

Is NCT04542291 still recruiting?

NCT04542291 is currently completed. Last updated 14 February 2023.

Are results published for NCT04542291?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-02-14 · How we verify

NCT04542291

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition

Completed Phase 1 Results posted Last updated 14 February 2023

What this trial tests

Phase 1 trial testing Dapagliflozin in Pancreas Cancer in 15 participants. Completed in 19 January 2022.

Timeline

25 February 2021

Primary endpoint
24 December 2021

19 January 2022

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	25 February 2021
Primary completion	24 December 2021
Estimated completion	19 January 2022
Sites	1 location across United States

Drugs / interventions tested

Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
BIOSENSE meters

Conditions studied

Pancreas Cancer — all drugs for Pancreas Cancer →
Pancreatic Cancer — all drugs for Pancreatic Cancer →
Cancer of the Pancreas — all drugs for Cancer of the Pancreas →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Pancreas Cancer or Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tolerability as Measured by Number of Participants With Related Adverse Events Primary · From start of treatment through 30 days after treatment (estimated to be 3 months)

* Adverse events will be graded with CTCAE v. 5.0. * Related indicates adverse events possibly, probably, or definitely related to treatment.

Anemia

Group	Value	95% CI
Dapagliflozin	15

Atrial fibrillation

Group	Value	95% CI
Dapagliflozin	1

Colitis

Group	Value	95% CI
Dapagliflozin	1

Constipation

Group	Value	95% CI
Dapagliflozin	1

Diarrhea

Group	Value	95% CI
Dapagliflozin	6

Dry mouth

Group	Value	95% CI
Dapagliflozin	1

Nausea

Group	Value	95% CI
Dapagliflozin	5

Vomiting

Group	Value	95% CI
Dapagliflozin	3

Changes in Plasma Glucose Secondary · Screening, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, and End of Treatment (estimated to be 2 months)

Screening

Group	Value	95% CI
Dapagliflozin	110	71 – 158

Cycle 1 Day 1

Group	Value	95% CI
Dapagliflozin	106.5	74 – 138

Cycle 1 Day 15

Group	Value	95% CI
Dapagliflozin	108.5	79 – 138

Cycle 2 Day 1

Group	Value	95% CI
Dapagliflozin	100.5	79 – 164

Cycle 2 Day 15

Group	Value	95% CI
Dapagliflozin	102.5	82 – 172

End of Treatment

Group	Value	95% CI
Dapagliflozin	98	81 – 195

Changes in Ketones Secondary · Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 2 Day 22

-Patients are to collect and test ketones weekly while on treatment.

Cycle 1 Day 1

Group	Value	95% CI
Dapagliflozin	0.5	0 – 5

Cycle 1 Day 8

Group	Value	95% CI
Dapagliflozin	0	0 – 5

Cycle 1 Day 15

Group	Value	95% CI
Dapagliflozin	0	0 – 5

Cycle 1 Day 22

Group	Value	95% CI
Dapagliflozin	0	0 – 5

Cycle 2 Day 1

Group	Value	95% CI
Dapagliflozin	0	0 – 5

Cycle 2 Day 8

Group	Value	95% CI
Dapagliflozin	0	0 – 5

Cycle 2 Day 15

Group	Value	95% CI
Dapagliflozin	0	0 – 5

Cycle 2 Day 22

Group	Value	95% CI
Dapagliflozin	0	0 – 5

Changes in HbA1c Secondary · Screening and Cycle 2 Day 15

Screening

Group	Value	95% CI
Dapagliflozin	5.95	4.2 – 7.2

Cycle 2 Day 15

Group	Value	95% CI
Dapagliflozin	5.95	5.2 – 7.2

Changes in CA19-9 Secondary · Cycle 1 Day 1, Cycle 2 Day 1, and End of Treatment, up to 8 weeks

Cycle 1 Day 1

Group	Value	95% CI
Dapagliflozin	1060	27.3 – 25010

Cycle 2 Day 1

Group	Value	95% CI
Dapagliflozin	315.6	23.3 – 9250

End of Treatment

Group	Value	95% CI
Dapagliflozin	256.1	11.3 – 30330

Changes in Total Fat Volume in Visceral Fat Area as Assessed by CT-based Body Composition Secondary · From pre-treatment and post-8 weeks of treatment

Pre-treatment

Group	Value	95% CI
Dapagliflozin	5009.845557	± 1894.271988

Post-8 weeks of treatment

Group	Value	95% CI
Dapagliflozin	4334.134004	± 2127.102525

Changes in Total Skeletal Muscle Volume in Visceral Fat Area as Assessed by CT-based Body Composition Secondary · From pre-treatment and post-8 weeks of treatment

Pre-treatment

Group	Value	95% CI
Dapagliflozin	1494.813884	± 324.0522377

Post-8 weeks of treatment

Group	Value	95% CI
Dapagliflozin	1360.211117	± 315.4997407

Changes in Total Muscle to Fat Ratio in Visceral Fat Area as Assessed by CT-based Body Composition Secondary · From pre-treatment and post-8 weeks of treatment

Pre-treatment

Group	Value	95% CI
Dapagliflozin	0.378776105	± 0.274872687

Post-8 weeks of treatment

Group	Value	95% CI
Dapagliflozin	0.518539627	± 0.638171644

Changes in CT-quantified Tumor Size Secondary · From pre-treatment and post-8 weeks of treatment

Pre-treatment

Group	Value	95% CI
Dapagliflozin	7.541666667	± 4.825775177

Post-8 weeks of treatment

Group	Value	95% CI
Dapagliflozin	7.358333333	± 5.946038916

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from start of treatment through 30 days after discontinuation of dapagliflozin. Treatment was 8 weeks in length. All-cause mortality was collected from start of treatment through completion of follow-up. Follow-up was an additional 3 months after completion of treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dapagliflozin

Serious: 5/15 (33%)

Deaths: 10/15

Serious adverse events (10 terms)

Reaction	System	Dapagliflozin
Atrial fibrillation	Cardiac disorders	—
Diarrhea	Gastrointestinal disorders	—
Obstruction gastric	Gastrointestinal disorders	—
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Fever	General disorders	—
Sepsis	Infections and infestations	—
Vascular access complication	Injury, poisoning and procedural complications	—
Flank pain	Musculoskeletal and connective tissue disorders	—
Hypotension	Vascular disorders	—

Other adverse events (77 terms — click to expand)

Reaction	System	Dapagliflozin
Anemia	Blood and lymphatic system disorders	—
Platelet count decreased	Investigations	—
Alopecia	Skin and subcutaneous tissue disorders	—
Diarrhea	Gastrointestinal disorders	—
White blood cell decreased	Investigations	—
Nausea	Gastrointestinal disorders	—
Alanine aminotransferase increased	Investigations	—
Anorexia	Investigations	—
Lymphocyte count decreased	Investigations	—
Hypoalbuminemia	Metabolism and nutrition disorders	—
Chills	General disorders	—
Edema limbs	General disorders	—
Alkaline phosphatase increased	Investigations	—
Neutrophil count decreased	Investigations	—
Hyponatremia	Metabolism and nutrition disorders	—
Fatigue	General disorders	—
Aspartate aminotransferase increased	Investigations	—
Constipation	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Peripheral sensory neuropathy	Nervous system disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Disease progression	General disorders	—
Fever	General disorders	—
Chronic kidney disease	Renal and urinary disorders	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—
Hypertension	Vascular disorders	—
Abdominal pain	Gastrointestinal disorders	—
Dyspepsia	Gastrointestinal disorders	—
Skin infection	Infections and infestations	—
Blood bicarbonate increased	Investigations	—
Blood bilirubin increased	Investigations	—
Hypokalemia	Metabolism and nutrition disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Glucosuria	Renal and urinary disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Atrial fibrillation, Diarrhea, Obstruction gastric, Upper gastrointestinal hemorrhage, Vomiting, Fever, Sepsis, Vascular access complication.

Data from ClinicalTrials.gov NCT04542291 adverse events section.

Sponsor's own description

This is a first-in-human, pilot study of the feasibility and safety of dapagliflozin (in addition to standard of care treatment) for the treatment of patients with metastatic pancreatic ductal adenocarcinoma. The primary hypothesis is that dapagliflozin is well-tolerated and safe to use in this patient population. The investigators also hypothesize that dapagliflozin will be efficacious as an adjunct to front-line chemotherapy assessed by decreased tumor markers mediated by its pleiotropic metabolic effects.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging mechanisms and promising approaches in pancreatic cancer metabolism.
Wu H, Fu M, Wu M, Cao Z, et al · · 2024 · cited 48× · PMID 39090116 · DOI 10.1038/s41419-024-06930-0
A local tumor microenvironment acquired super-enhancer induces an oncogenic driver in colorectal carcinoma.
Zhou RW, Xu J, Martin TC, Zachem AL, et al · · 2022 · cited 30× · PMID 36253360 · DOI 10.1038/s41467-022-33377-8
Nutrient transporters: connecting cancer metabolism to therapeutic opportunities.
Nwosu ZC, Song MG, di Magliano MP, Lyssiotis CA, et al · · 2023 · cited 29× · PMID 36739364 · DOI 10.1038/s41388-023-02593-x
Overcoming chemoresistance by targeting reprogrammed metabolism: the Achilles' heel of pancreatic ductal adenocarcinoma.
Tuerhong A, Xu J, Shi S, Tan Z, et al · · 2021 · cited 26× · PMID 34131808 · DOI 10.1007/s00018-021-03866-y
The Glycolytic Pathway as a Target for Novel Onco-Immunology Therapies in Pancreatic Cancer.
Curcio C, Brugiapaglia S, Bulfamante S, Follia L, et al · · 2021 · cited 23× · PMID 33804240 · DOI 10.3390/molecules26061642
Safety, tolerability, and effectiveness of the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin in combination with standard chemotherapy for patients with advanced, inoperable pancreatic adenocarcinoma: a phase 1b observational study.
Park LK, Lim KH, Volkman J, Abdiannia M, et al · · 2023 · cited 21× · PMID 37202813 · DOI 10.1186/s40170-023-00306-2
Obesity-Associated Colorectal Cancer.
Gonzalez-Gutierrez L, Motiño O, Barriuso D, de la Puente-Aldea J, et al · · 2024 · cited 18× · PMID 39201522 · DOI 10.3390/ijms25168836
Metabolic Signaling in the Tumor Microenvironment.
Clay R, Li K, Jin L. · · 2025 · cited 8× · PMID 39796781 · DOI 10.3390/cancers17010155

Verify or expand the search:

Other trials of Dapagliflozin

Trials testing the same drug.

NCT07491042 — Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients. · NA · recruiting
NCT07351643 — CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes in Non-diabetic ACS Patients Without HF · Phase 4 · not yet recruiting
NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
NCT07239011 — Dapagliflozin in Depression · Phase 1, PHASE2 · recruiting
NCT06851962 — Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. · Phase 4 · active not recruiting

Other recruiting trials for Pancreas Cancer

Currently open trials in the same condition.

NCT07126158 — Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma · Phase 2 · recruiting
NCT07230509 — Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate · Phase 2 · recruiting
NCT06926075 — Early Phase Study of KESONOTIDE™in Participants With Solid Tumours · Phase 1, PHASE2 · recruiting
NCT07179692 — CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors · Phase 1 · recruiting
NCT07132541 — Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate) · Phase 1 · recruiting

Other Washington University School of Medicine trials

Trials by the same sponsor.

NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04542291 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 14 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04542291.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04542291

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (10 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Dapagliflozin

Other recruiting trials for Pancreas Cancer

Other Washington University School of Medicine trials

Verify against primary sources