Brenzavvy (bexagliflozin)

To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise Drug Trials Snapshot

FDA Approval: 1/20/2023

Research Synopsis

  • - **Brenzavvy (bexagliflozin)** is a newly approved **SGLT2 inhibitor** targeting type 2 diabetes (T2D) management, showing potential for improved glycemic control.
  • - Initial studies demonstrated bexagliflozin's effectiveness in reducing **HbA1c levels**, body weight, and systolic blood pressure in patients with T2D and chronic kidney disease (CKD).
  • - A Phase 3 trial revealed that bexagliflozin significantly lowered HbA1c by **0.37%**, and it was well tolerated, with fewer serious adverse events reported.
  • - Compared to sitagliptin, bexagliflozin proved equally effective for HbA1c reduction, while outperforming in lowering **fasting plasma glucose** and body weight.
  • - Bexagliflozin can be safely used as a monotherapy and in combination with metformin or other diabetes medications, enhancing overall management of T2D.
  • - Meta-analyses indicate that bexagliflozin offers significant improvements in HbA1c, body weight, and blood pressure without increasing adverse effects, positioning it as a valuable treatment option.
  • - Recent evaluations of bexagliflozin in **animal studies** (specifically in diabetic cats) showed promise, with many experiencing significant improvements in hyperglycemia and reduced insulin needs.
  • - Studies highlight the medication’s **renal protective effects** in patients with CKD, thereby presenting benefits beyond traditional glycemic control.
  • - In comprehensive reviews, bexagliflozin is recognized for its safety and effectiveness in managing T2D and CKD, suggesting further studies may solidify its role in diabetes care.
  • - The drug received approval from the FDA in January 2023, marking a significant advancement in diabetes therapy, although it is not suitable for certain patient populations.

Related articles

Research articles about Brenzavvy (bexagliflozin)

Brenzavvy (bexagliflozin)

Safety and Effectiveness of Bexagliflozin in Patients With Type 2 Diabetes Mellitus and Stage 3a/3b CKD.

London, UK

2 hours ago

1 Received

  • Hyperglycemia can worsen chronic kidney disease (CKD), and traditional diabetes treatments often don't help CKD-related problems; bexagliflozin, an SGLT2 inhibitor, was studied for its potential effectiveness in patients with diabetes and CKD.
  • A Phase 3, double-blind trial involved 312 participants with type 2 diabetes and CKD stages 3a and 3b across 54 sites in 4 countries, comparing the effects of 20mg of bexagliflozin to a placebo over 24 weeks.
  • Results showed bexagliflozin significantly reduced hemoglobin A1c levels by 0.37%, lowered body weight, systolic blood pressure, fasting

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A 96-week, multinational, randomized, double-blind, parallel-group, clinical trial evaluating the safety and effectiveness of bexagliflozin as a monotherapy for adults with type 2 diabetes.

London, UK

2 hours ago

1 Received

  • The study aimed to assess the safety and effectiveness of bexagliflozin, a medication for type 2 diabetes, over a 96-week period compared to a placebo.
  • It involved 288 adults from the USA, Colombia, and Mexico, showing a significant reduction in HbA1c levels and beneficial changes in body mass and blood pressure for those taking bexagliflozin.
  • The results indicated that bexagliflozin was well tolerated, with fewer serious adverse events and urinary tract infections compared to the placebo group, demonstrating it provided meaningful improvements in diabetes management.

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A 12-week, randomized, double-blind, placebo-controlled, four-arm dose-finding phase 2 study evaluating bexagliflozin as monotherapy for adults with type 2 diabetes.

London, UK

2 hours ago

1 Received

  • - A study was conducted to assess the safety and effectiveness of bexagliflozin, a medication for type 2 diabetes, at three different doses (5, 10, and 20 mg) over 12 weeks, comparing it to a placebo in patients who had minimal previous medication exposure.
  • - Results showed that all doses of bexagliflozin significantly reduced HbA1c levels, with the 20 mg dose showing the most substantial decrease, along with improvements in fasting plasma glucose and body mass.
  • - The medication had a similar incidence of adverse effects as the placebo, indicating it is generally safe; further research is recommended to explore its long-term effects for managing type 2 diabetes.

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Metabolism and disposition of the SGLT2 inhibitor bexagliflozin in rats, monkeys and humans.

London, UK

2 hours ago

1 Received

  • - Bexagliflozin, an SGLT2 inhibitor, is metabolized in humans through oxidation and glucuronidation, primarily involving CYP3A4 and UGT1A9, leading to six key metabolites.
  • - Human metabolism primarily produces glucuronide metabolites, and while rat metabolism favors oxidation, monkey metabolism closely parallels human metabolism, sharing all identified metabolites.
  • - After ingesting bexagliflozin, the 3'-glucuronide is the main metabolite in circulation, contributing significantly to the drug's overall presence in the body, with a notable percentage recaptured in feces and urine.

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An exhaustive perspective on structural insights of SGLT2 inhibitors: A novel class of antidiabetic agent.

London, UK

2 hours ago

1 Received

  • Diabetes mellitus is a growing global health issue, with significant prevalence rates in developed countries like the USA, China, and India, highlighting a need for new treatments as the number of diabetic patients continues to rise.
  • The sodium-glucose co-transporter 2 (SGLT2) has emerged as a key target for Type 2 diabetes treatment, due to its unique mechanism of action that doesn’t involve insulin signaling.
  • Various SGLT2 inhibitors, including dapagliflozin and its analogues, are currently being explored in clinical trials, with ongoing research focused on their chemical structures and effectiveness in managing diabetes.

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Bexagliflozin for type 2 diabetes: an overview of the data.

London, UK

2 hours ago

1 Received

  • * These drugs have been shown to improve cardiovascular and kidney health in patients with type 2 diabetes (T2D) and may also help non-diabetic patients with chronic kidney disease (CKD) or heart failure.
  • * Bexagliflozin, a new SGLT2 inhibitor, shows promise similar to other drugs in its class, demonstrating safety and effectiveness in patients with diabetes and CKD stage 3b, offering potential new treatment options for T2D and related conditions.

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Evaluation of bexagliflozin in cats with poorly regulated diabetes mellitus.

London, UK

2 hours ago

1 Received

  • - The study aimed to examine how the drug bexagliflozin affects blood sugar control in poorly managed diabetic cats over a 4-week period while monitoring for any negative side effects.
  • - Five cats on insulin therapy participated, showing a notable decrease in their insulin needs, with two cats completely stopping insulin treatment.
  • - Blood glucose levels improved significantly during the study, and while serum fructosamine levels dropped in four cats, this wasn't a statistically significant change; overall, the drug had mild side effects and positively impacted diabetic management.

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Renal protective effect and safety of sodium-glucose cotransporter-2 inhibitors in patients with chronic kidney disease and type 2 diabetes mellitus: a network meta-analysis and systematic review.

London, UK

2 hours ago

1 Received

  • A network meta-analysis was performed to assess the effects and safety of sodium-glucose cotransporter-2 inhibitors on patients with chronic kidney disease and type 2 diabetes.
  • Key findings showed that luseogliflozin, bexagliflozin, and dapagliflozin decreased the estimated glomerular filtration rate (eGFR) and urine albumin-creatinine ratio levels compared to control treatments.
  • Overall, these medications demonstrated beneficial renal protection and safety, though further randomized clinical trials are necessary for confirmation.

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Meta-analysis Addressing the Cardiovascular Safety of Bexagliflozin in Patients With Type 2 Diabetes Mellitus.

London, UK

2 hours ago

1 Received

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A 96-week, double-blind, randomized controlled trial comparing bexagliflozin to glimepiride as an adjunct to metformin for the treatment of type 2 diabetes in adults.

London, UK

2 hours ago

1 Received

  • The study aimed to compare the effectiveness of bexagliflozin tablets (20 mg) versus glimepiride in treating adults with type 2 diabetes who weren't adequately controlled by metformin.
  • A total of 426 adults were randomized, with the primary focus on changes in glycated hemoglobin (HbA1c) levels after 60 weeks, while secondary outcomes included body mass, blood pressure, and hypoglycemia occurrences.
  • Results showed bexagliflozin was noninferior to glimepiride in reducing HbA1c, outperformed it in reducing body weight and blood pressure, and led to fewer instances of hypoglycemia, along with a positive impact on kidney function.

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Bexagliflozin: First Approval.

London, UK

2 hours ago

1 Received

  • Bexagliflozin (BRENZAVVY™) is a new oral medication that inhibits sodium-glucose transporter 2 (SGLT-2) and is being developed for type 2 diabetes (T2D) and high blood pressure.
  • It received its first approval in January 2023 in the USA for helping adults with T2D improve blood sugar control when combined with diet and exercise.
  • The drug is not suitable for patients on dialysis, those with type 1 diabetes, or individuals with severely reduced kidney function, and it is also being studied for treating essential hypertension.

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Efficacy and safety of bexagliflozin in patients with type 2 diabetes mellitus: A systematic review and meta-analysis.

London, UK

2 hours ago

1 Received

  • The study aimed to evaluate how effective bexagliflozin is in lowering glycated hemoglobin (HbA1c) and monitoring side effects in patients with type 2 diabetes (T2DM).
  • Six randomized, placebo-controlled clinical trials involving a total of 3,111 patients were analyzed, revealing that bexagliflozin significantly reduced HbA1c, fasting plasma glucose, blood pressure, and body weight compared to placebo.
  • The findings concluded that bexagliflozin improves clinical outcomes in T2DM patients without increasing the risk of side effects, confirming its efficacy as a treatment option.

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Cardiovascular Diseases: Therapeutic Potential of SGLT-2 Inhibitors.

London, UK

2 hours ago

1 Received

  • Cardiovascular diseases (CVD) represent a significant global health issue, being the leading cause of illness and death, highlighting the importance of effective treatments.
  • Sodium/glucose cotransporter 2 (SGLT2) inhibitors, originally designed for type 2 diabetes management, show notable cardiovascular benefits, making them a promising option for CVD treatment.
  • The paper focuses on the therapeutic potential of various SGLT2 inhibitors like empagliflozin and dapagliflozin, which have proven effective in improving cardiovascular health and kidney protection, but emphasizes the need for ongoing research to fully understand their benefits and mechanisms.

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Bexagliflozin (Brenzavvy) - A fifth SGLT2 inhibitor for type 2 diabetes.

London, UK

2 hours ago

1 Received

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Safety and effectiveness of the sodium-glucose cotransporter inhibitor bexagliflozin in cats newly diagnosed with diabetes mellitus.

London, UK

2 hours ago

1 Received

  • Bexagliflozin, an SGLT2 inhibitor, shows potential as a treatment for diabetes mellitus (DM) in cats, reducing their need for insulin.
  • In a study involving 84 cats, 84% experienced significant improvements in hyperglycemia and clinical symptoms after 56 days of daily administration.
  • While many cats benefited from the treatment, some faced serious side effects, including diabetic ketoacidosis, highlighting the need for careful monitoring.

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Bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes in adults: A 24-week, randomized, double-blind, placebo-controlled trial.

London, UK

2 hours ago

1 Received

  • The study aimed to assess the safety and effectiveness of bexagliflozin when used alongside metformin for treating type 2 diabetes in 317 participants.
  • Results showed that bexagliflozin led to a significant reduction in HbA1c levels compared to the placebo, with an impressive mean change of -1.09% versus -0.56%.
  • Both systolic blood pressure, fasting plasma glucose, and weight loss also improved in the bexagliflozin group, and fewer serious adverse events were reported compared to the placebo group, indicating that bexagliflozin is a beneficial addition to metformin therapy.

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Bexagliflozin.

London, UK

2 hours ago

1 Received

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In brief: Empagliflozin (Jardiance) for chronic kidney disease.

London, UK

2 hours ago

1 Received

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Bexagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for improvement of glycemia in type 2 diabetes mellitus: a systematic review and meta-analysis.

London, UK

2 hours ago

1 Received

  • - This study evaluated the safety and effectiveness of bexagliflozin, an SGLT2 inhibitor, in treating glycemia in patients with type 2 diabetes, using data from randomized controlled trials (RCTs) up to May 2023.
  • - It analyzed the impact of a daily dose of 20 mg of bexagliflozin on factors like body weight, fasting plasma sugar, blood pressure, and the percentage of patients achieving a target HbA1c of <7%, finding significant reductions compared to a placebo.
  • - The results showed that bexagliflozin effectively lowered HbA1c, fasting plasma sugar, body weight, and systolic blood pressure without additional safety concerns, indicating it

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