Dapagliflozin for Type 2 Diabetes

(SFRNDM2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Naomi M Hamburg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Boston University

Must not be taking: Anticoagulants, SGLT-2 inhibitors

Disqualifiers: Pregnancy, Renal failure, Cancer, others

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

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.

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).

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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.

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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.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

BU School of Medicine Evans 748 Boston, MA

Who Is Running the Clinical Trial?

Boston University Lead Sponsor

American Heart Association Collaborator

References

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

Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. [2021] To review clinical evidence for the efficacy, safety, and tolerability of dapagliflozin (Farxiga-AstraZeneca), a sodium glucose cotransporter 2 inhibitor, as monotherapy or in combination with other hypoglycemic agents for the treatment of type 2 diabetes.

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

[Dapagliflozin (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes]. [2021] Dapagliflozin, a specific inhibitor of sodium-glu¬cose cotransporters type 2 (SGLT2, inhibits glucose reabsorp¬tion in renal tubules and thus promotes glucosuria. This effect results in a reduction in fasting and postprandial glycaemia and a decrease of glycated haemoglobin (HbA1c), with a minor risk of hypoglycaemia, a weight reduction and a reduction in arterial blood pressure. The efficacy of empagliflozin on HbA1c reduction increases according to the level of hyper¬glycaemia but decreases in patients with renal insufficiency. Mycotic genital infections occur more frequently, especially in women, while a negligible increase in mild urinary tract infections may be observed. Dapagliflozin (Forxiga®), 10 mg once daily, is indicated for the treatment of T2DM and reim¬bursed in Belgium with conditions as add-on to a background glucose-lowering therapy (either metformin or sulfonylurea/ repaglinide or metformin plus sulfonylurea/repaglinide or basal insulin plus at least one of these oral glucose-lowering agents). Preliminary results suggest some cardiovascular and renal protection. These results should be confirmed in an ongoing large prospective controlled trial (DECLARE) in type 2 diabetic patients at high cardiovascular risk.

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

Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. [2021] Dapagliflozin (DAPA) (Farxiga or Forxiga) is a sodium glucose cotransporter 2 (SGLT2) inhibitor approved for type 2 diabetes mellitus(T2DM) treatment.

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

Dapagliflozin: a review of its use in patients with type 2 diabetes. [2022] Dapagliflozin (Forxiga(®), Farxiga(®)) is an orally administered sodium-glucose co-transporter-2 (SGLT2) inhibitor used in the management of patients with type 2 diabetes. Dapagliflozin reduces renal glucose reabsorption by inhibiting the transporter protein SGLT2 in the renal proximal tubule, thereby increasing urinary glucose excretion and reducing blood glucose levels. Its mechanism of action is independent of insulin secretion or action; therefore, dapagliflozin provides complementary therapy when used in combination with other antihyperglycaemic drugs. This article updates an earlier review of dapagliflozin and focuses on longer-term efficacy and tolerability data (e.g. from extensions of earlier clinical trials), as well as data from studies in special patient populations (e.g. history of cardiovascular disease). Numerous well-designed clinical trials with dapagliflozin, primarily as add-on therapy for 24 weeks (but also as monotherapy or initial combination therapy), have consistently demonstrated reductions in glycosylated haemoglobin, fasting plasma glucose levels and bodyweight. Extensions of these trials show the effects are maintained over longer-term follow-up periods of ≈1-4 years and dapagliflozin is generally well tolerated. Dapagliflozin has a low risk of hypoglycaemia, although the incidence varies depending on background therapy, and genital mycotic infections (particularly in women) are the most common adverse events. Dapagliflozin is not recommended in patients with moderate or severe renal impairment. In view of its unique mechanism of action and now well-established efficacy and tolerability profile, dapagliflozin is a useful treatment option in the management of type 2 diabetes, although its effects on diabetic complications remain to be evaluated.

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

Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. [2023] Dapagliflozin (Farxiga) is now approved to reduce the risk of declining kidney function, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease with or without type 2 diabetes.

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

Dapagliflozin no longer licensed for type 1 diabetes. [2022] Overview of: Medicines and Healthcare products Regulatory Agency. Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus. Drug Safety Update 2021;15:3.