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SGLT2 Inhibitor

Dapagliflozin for Cardiovascular Risk (DAPA-SWEET Trial)

Phase 2
Recruiting
Led By David ZI Cherney, MD PhD FRCPC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial looks at how a diabetes medication affects various aspects of heart and kidney health in people with and without diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Arterial stiffness
Secondary study objectives
Bioimpedence spectroscopy
Echocardiography
Flow mediated dilation
+13 more

Side effects data

From 2023 Phase 3 trial • 240 Patients • NCT04298229
8%
Hypoglycemia
7%
HF exacerbation
4%
Death
1%
Severe Hypotension
1%
Acute Kidney Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Structured Usual Care
Dapagliflozin + Structured Usual Care

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dapagliflozin Treatment ArmExperimental Treatment1 Intervention
Dapagliflozin Tablets Total Dose 10mg daily for 12 weeks
Group II: Placebo ArmPlacebo Group1 Intervention
Placebo Matching Dapagliflozin Tablet for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreOTHER
681 Previous Clinical Trials
1,565,708 Total Patients Enrolled
MOUNT SINAI HOSPITALOTHER
42 Previous Clinical Trials
16,930 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,272 Total Patients Enrolled
David ZI Cherney, MD PhD FRCPCPrincipal InvestigatorUniversity Health Network, Toronto General Hospital
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Dapagliflozin 10 MG (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04258371 — Phase 2
Cardiovascular Risk Research Study Groups: Placebo Arm, Dapagliflozin Treatment Arm
Cardiovascular Risk Clinical Trial 2023: Dapagliflozin 10 MG Highlights & Side Effects. Trial Name: NCT04258371 — Phase 2
Dapagliflozin 10 MG (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258371 — Phase 2
~9 spots leftby Dec 2025
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