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Sodium-Glucose Cotransporter-2 inhibitor

Dapagliflozin for Type 2 Diabetes (SFRNDM2 Trial)

Phase 4
Recruiting
Led By Naomi M Hamburg, MD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of T2DM for minimum of 3 months defined as fasting glucose greater than or equal to 120 mg/dL, hemoglobin A1C (HbA1C) ≥6.5%
Be older than 18 years old
Must not have
History of bladder cancer or prior pelvic radiation
Treatment with anticoagulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests dapagliflozin, a medication that lowers blood sugar by increasing sugar removal through urine, in patients with Type 2 Diabetes. These patients are at higher risk for heart attacks and strokes. The study aims to see if dapagliflozin can improve their heart and blood vessel health.

Who is the study for?
This trial is for adults with Type 2 Diabetes Mellitus (T2DM) who have a BMI over 25 and have been diagnosed for at least 3 months. They must not be on anticoagulants, have had bladder cancer or pelvic radiation, recurrent urinary infections, genital mycotic infections, or severe illnesses including renal failure.
What is being tested?
The study tests the effects of Dapagliflozin, an SGLT2 inhibitor drug that might improve heart and blood vessel health in T2DM patients. It will be compared to a placebo to see if it changes vascular health markers like arterial stiffness and endothelial cell function.
What are the potential side effects?
Dapagliflozin may cause dehydration leading to low blood pressure, yeast infections in genitals due to sugar in urine attracting fungi, increased urination frequency, potential kidney problems and risk of diabetic ketoacidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 2 diabetes for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had bladder cancer or radiation treatment in the pelvic area.
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I am currently on blood thinners.
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I have had 3 or more urinary tract infections in the last year.
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I am taking medication for diabetes that belongs to the SGLT-2 inhibitors class.
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I've had more than one low blood sugar event in the past 6 months or my HbA1c is below 7.0%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 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
Insulin-mediated endothelial nitric oxide synthase (eNOS) phosphorylation measured in endothelial cells (ECs) at 14 weeks
Insulin-mediated endothelial nitric oxide synthase (eNOS) phosphorylation measured in endothelial cells (ECs) at 6 weeks
Secondary study objectives
Arterial stiffness at 14weeks
Arterial stiffness at 6 weeks
Circulating C-reactive protein (CRP) biomarkers of vascular health at 14 weeks
+13 more

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dapagliflozin then PlaceboExperimental Treatment2 Interventions
Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between.
Group II: Placebo then dapagliflozinPlacebo Group2 Interventions
Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64440

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor
472 Previous Clinical Trials
9,987,776 Total Patients Enrolled
4 Trials studying Diabetes
8,449 Patients Enrolled for Diabetes
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,483 Total Patients Enrolled
4 Trials studying Diabetes
491 Patients Enrolled for Diabetes
Naomi M Hamburg, MDPrincipal InvestigatorBU School of Medicine, Cardiovascular Medicine
2 Previous Clinical Trials
43 Total Patients Enrolled

Media Library

Dapagliflozin (Sodium-Glucose Cotransporter-2 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05139914 — Phase 4
Diabetes Research Study Groups: Dapagliflozin then Placebo, Placebo then dapagliflozin
Diabetes Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT05139914 — Phase 4
Dapagliflozin (Sodium-Glucose Cotransporter-2 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139914 — Phase 4
~0 spots leftby Dec 2024
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