Dapagliflozin for Type 2 Diabetes

(SFRNDM2 Trial)

Overseen By Leili Behrooz, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston University

Must not be taking: Anticoagulants, SGLT-2 inhibitors

Disqualifiers: Pregnancy, Renal failure, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how dapagliflozin (also known as Farxiga or Forxiga) can aid people with Type 2 Diabetes by improving blood vessel health, potentially reducing the risk of heart attacks or strokes. Researchers aim to determine if dapagliflozin enhances blood vessel function and beneficially alters certain cell types. Participants will either take dapagliflozin first and then a placebo (a pill with no medicine), or the reverse, with a short break in between. This trial suits individuals who have had Type 2 Diabetes for at least three months, have a body mass index over 25, and are not currently on certain diabetes medications. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective dapagliflozin can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking any SGLT-2 inhibitors and anticoagulation medications. If you are on these medications, you would need to discontinue them to participate.

What is the safety track record for dapagliflozin?

Research has shown that dapagliflozin, a treatment for type 2 diabetes, is generally safe. In a study with nearly 600 patients, dapagliflozin proved effective and safe, with many patients experiencing improved health. Another study found that dapagliflozin was as safe for children as for adults, indicating it is well-tolerated across age groups.

Additionally, research found that dapagliflozin did not increase the risk of major heart problems, such as heart attacks or strokes, compared to a placebo. It even helped lower the risk of death from heart-related issues. Overall, these studies suggest that dapagliflozin is a safe choice for people with type 2 diabetes. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dapagliflozin is unique because it works by inhibiting a protein called SGLT2, which plays a key role in glucose reabsorption in the kidneys. Unlike many standard treatments for Type 2 diabetes that increase insulin levels or affect insulin sensitivity, dapagliflozin helps the body eliminate excess glucose through urine. This mechanism not only lowers blood sugar levels but may also offer benefits like weight loss and reduced blood pressure. Researchers are excited about dapagliflozin because it provides an alternative approach to managing Type 2 diabetes, expanding treatment options for patients who may not respond well to existing therapies.

What is the effectiveness track record for dapagliflozin in improving vascular health in patients with Type 2 Diabetes?

Research has shown that dapagliflozin helps manage Type 2 Diabetes. One study found it lowered the systolic blood pressure by about 2.4 points compared to a placebo. This is important because high blood pressure can lead to heart problems. In this trial, participants will receive dapagliflozin in one arm and a placebo in another, with a washout period in between. Dapagliflozin has also been shown to reduce the risk of death from heart issues or hospitalization for heart failure. This means it can help protect the heart and blood vessels in people with Type 2 Diabetes. ^{3 6 7 8 9}

Who Is on the Research Team?

Naomi M Hamburg, MD

Principal Investigator

BU School of Medicine, Cardiovascular Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with type 2 diabetes for at least 3 months.

Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.

Your body mass index (BMI) is higher than 25.

Exclusion Criteria

Treatment with an investigational product within the last 30 days.

I do not have any major illnesses like severe kidney problems or other cancers.

I am currently on blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive dapagliflozin or placebo for 6 weeks

6 weeks

Regular visits for monitoring and assessments

Washout

A 2-week washout period between treatment periods

2 weeks

Treatment Period 2

Participants crossover to receive the alternate treatment (dapagliflozin or placebo) for 6 weeks

6 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dapagliflozin

Trial Overview

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.

How Is the Trial Designed?

Group I: Dapagliflozin then Placebo Experimental Treatment 2 Interventions

Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between.

Group II: Placebo then dapagliflozin Placebo Group 2 Interventions

Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between.

Dapagliflozin is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Forxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Approved in United States as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Approved in Canada as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Dapagliflozin (Farxiga) is approved for reducing the risk of declining kidney function and kidney failure in adults with chronic kidney disease, regardless of whether they have type 2 diabetes.

It also helps lower the risk of cardiovascular death and hospitalization for heart failure, highlighting its efficacy in managing both kidney and heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. Aschenbrenner, DS.[2023]

Dapagliflozin (Forxiga) is no longer authorized for the treatment of type 1 diabetes mellitus, indicating a significant change in its regulatory status.

This decision reflects safety concerns or efficacy issues that may have arisen from clinical evaluations or post-marketing surveillance, emphasizing the importance of ongoing drug safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin no longer licensed for type 1 diabetes. [2022]

Dapagliflozin (DAPA) is an effective SGLT2 inhibitor for treating type 2 diabetes, showing favorable pharmacokinetics and pharmacodynamics that help lower blood sugar levels while having beneficial effects on other metabolic risk factors.

While DAPA is generally safe, it carries an increased risk of genital and urinary infections, and concerns about bladder cancer and cardiovascular safety remain, prompting the FDA to seek further data on these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. Maranghi, M., Carnovale, A., Durante, C., et al.[2021]

Dapagliflozin is an effective treatment for type 2 diabetes, proven through multiple controlled clinical trials that assess its efficacy, safety, and tolerability.

It is approved by the FDA for use as a standalone therapy or in combination with other glucose-lowering medications, including insulin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. Davis, PN., Ndefo, UA., Oliver, A.[2021]

Dapagliflozin effectively lowers blood sugar levels and glycated hemoglobin (HbA1c) in patients with type 2 diabetes, with a low risk of hypoglycemia and additional benefits like weight loss and reduced blood pressure.

While it is generally safe, dapagliflozin can increase the risk of genital infections, particularly in women, and its efficacy may be reduced in patients with kidney issues; ongoing trials are investigating its potential cardiovascular and renal protective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dapagliflozin (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes]. Scheen, AJ.[2021]

Dapagliflozin is an effective SGLT2 inhibitor for managing type 2 diabetes, showing consistent reductions in blood glucose levels and body weight over long-term follow-up periods of 1-4 years across various clinical trials.

It has a low risk of causing hypoglycemia and is generally well tolerated, although it can lead to genital infections, particularly in women, and is not recommended for patients with moderate to severe renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: a review of its use in patients with type 2 diabetes. Plosker, GL.[2022]

Citations

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Efficacy and Safety of Dapagliflozin in Type 2 Diabetes ...

Overall, dapagliflozin reduced SBP by 2.4 mm Hg (95% CI, 1.9-2.9; P<0.0001) compared with placebo at 48 months. The beneficial effects of ...

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ahajournals.org

ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.058103

Efficacy and Safety of Dapagliflozin in Type 2 Diabetes ...

Overall, dapagliflozin reduced SBP by 2.4 mm Hg (95% CI, 1.9–2.9; P<0.0001) compared with placebo at 48 months. The beneficial effects of ...

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1812389

Dapagliflozin and Cardiovascular Outcomes in Type 2 ...

With respect to efficacy, dapagliflozin resulted in a lower rate of cardiovascular death or hospitalization for heart failure than placebo (4.9% ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2772417424000396

A new hope for the therapeutic treatment of type 2 diabetes ...

According to an analysis of a phase IIb/III clinical trial, Dapagliflozin results in a higher incidence (1.1%) of volume depletion in comparison to the placebo ...

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jamanetwork.com/journals/jamacardiology/fullarticle/2794142

Efficacy and Safety of Dapagliflozin According to ...

Dapagliflozin consistently reduced the risk of a composite of CV death or hospitalization for heart failure (HHF), HHF alone, and progression of kidney disease.

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Efficacy and safety of dapagliflozin in patients hospitalized ...

Among patients with T2D, the prevention outcome occurred in 10.9% receiving dapagliflozin versus 13.9% receiving placebo (hazard ratio [HR] 0.76 ...

7.

pubmed.ncbi.nlm.nih.gov

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Efficacy and Safety of Dapagliflozin According to ...

Dapagliflozin consistently reduced the risk of CV and kidney outcomes irrespective of background use of various CV medications without any treatment ...

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Effectiveness and safety of dapagliflozin in real-life patients

In this study, the effectiveness and safety of dapagliflozin were analysed in nearly 600 patients with T2D, showing a high capacity of dapagliflozin to reduce ...

9.

accessdata.fda.gov

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FARXIGA® (dapagliflozin) tablets, for oral use

The safety profile observed in the placebo-controlled trial in pediatric patients with type 2 diabetes mellitus was similar to that observed in adults [see ...