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 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.

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.

Is dapagliflozin safe for humans?

Dapagliflozin is generally well tolerated in humans, with a low risk of low blood sugar (hypoglycemia) and the most common side effect being genital infections, especially in women. It is not recommended for people with moderate or severe kidney problems. ^{1 2 3 4 5}

What makes the drug dapagliflozin unique for treating type 2 diabetes?

Dapagliflozin is unique because it works by blocking a protein in the kidneys that reabsorbs glucose, leading to more sugar being excreted in urine, which helps lower blood sugar levels. Unlike many other diabetes medications, it does not rely on insulin to be effective, and it also offers benefits like weight loss and reduced blood pressure. ^{1 2 3 4 6}

What data supports the effectiveness of the drug Dapagliflozin for treating type 2 diabetes?

Dapagliflozin helps lower blood sugar levels by making the kidneys remove more sugar through urine, and it can also help with weight loss and lowering blood pressure. It has been shown to reduce blood sugar levels and maintain these effects over time, with a low risk of causing dangerously low blood sugar (hypoglycemia). ^{1 2 3 4 6}

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 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 (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 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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. [2021]

2. Belgium pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

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