Segluromet (ertugliflozin/metformin) / Pfizer, Merck (MSD) - LARVOL DELTA

CER-4-T2D: Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study (clinicaltrials.gov) - P=N/A | N=781430 | Active, not recruiting | Sponsor: Brigham and Women's Hospital | Trial completion date: Jul 2024 ➔ Jul 2026 | Trial primary completion date: Jul 2024 ➔ Jan 2026

HEOR • Trial completion date • Trial primary completion date • Cardiovascular • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets and Reference Product (R) of Segluromet 7.5 mg/ 1000 mg Film Coated Tablets in Healthy, Adult, Human Subjects Under Fed Condition. (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Humanis Saglık Anonim Sirketi

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparison chart: Sodium-glucose cotransporter 2 (SGLT2) inhibitors. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Noninsulin drugs for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Molecular interactions of diabetes medications with alzheimer's related targets by molecular docking. (PubMed, J Diabetes Metab Disord) - "This study investigates the potential of two commonly prescribed diabetes medications, Ertugliflozin and Sitagliptin, to impact Alzheimer's disease-related factors...In this study, Metformin was utilized as the positive control ligand...By potentially inhibiting these factors, the drugs could exhibit a dual action, benefiting both diabetes and Alzheimer's. Further in vivo and clinical studies are needed to confirm these observations."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Diabetes • Hypoglycemia • Metabolic Disorders • Pain

Examining the Impact of Ertugliflozin on Cardiovascular Outcomes in Patients with Diabetes and Metabolic Syndrome: A Systematic Review of Clinical Trials. (PubMed, Pharmaceuticals (Basel)) - "Furthermore, when combined with metformin, ertugliflozin potentially reduced MACEs (HR 0.92, 95% CI 0.79-1.07), although this finding did not reach statistical significance. These results endorse the integration of ertugliflozin into therapeutic protocols for T2DM patients at elevated cardiovascular risk and substantiate its efficacy among SGLT2 inhibitors. Continued investigations are recommended to delineate its long-term cardiovascular benefits in diverse patient populations, including the potential impact on arrhythmias."

Journal • Review • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Type 2 Diabetes Mellitus

Drugs for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

SOLDMiDiab02: Evaluation of SGLT2-i Effectivness and Safety in Elderly Type 2 Diabetes Patients (clinicaltrials.gov) - P=N/A | N=800 | Not yet recruiting | Sponsor: University of Milan

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

CER-4-T2D: Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study (clinicaltrials.gov) - P=N/A | N=781430 | Active, not recruiting | Sponsor: Brigham and Women's Hospital

HEOR • New trial • Cardiovascular • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

"انتظار می‌رود که Steglatro و Steglujan در ژانویه‌ و Segluromet در ماه فوریه‌ی 2018، در آمریکا با نسخه ی پزشک در دسترس بیماران قرار گیرد..سعی کنید از این دارو به دقت استفاده کنید@merck #bigpharma" (@alidoki1)

"بر روی برچسب جعبه‌ی Segluromet هشداری در مورد لاکتیک اسیدوز آمده است..حتما از تاریخ تولید داروها مطمین باشید@merck #death" (@KazemLali)

Bioequivalence of Metformin in Ertugliflozin/Metformin Fixed-Dose Combination Tablets to Canadian-Sourced Metformin Coadministered With Ertugliflozin Under Fasted and Fed States. (PubMed, Clin Pharmacol Drug Dev) - "All study medications were well tolerated. Bioequivalence was demonstrated for the metformin component of the ertugliflozin/metformin FDC tablets and the corresponding doses of the Canadian-sourced metformin coadministered with ertugliflozin."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Ertugliflozin alone and in fixed-dose combinations : «pass of three» (PubMed, Rev Med Liege) - "This SGLT2i is also available in fixed-dose combinations, ertugliflozin-metformin and ertugliflozin-sitagliptin. The three presentations offer a greater flexibility to the practitioner to optimize therapeutic choices for a complex disease where the treatment should be individualized according to the patient profile."

Journal • Cardiovascular • Diabetes • Hypoglycemia • Metabolic Disorders • Mycosis Fungoides • Type 2 Diabetes Mellitus

Effect of Food on the Pharmacokinetics of Ertugliflozin and Its Fixed-Dose Combinations Ertugliflozin/Sitagliptin and Ertugliflozin/Metformin. (PubMed, Clin Pharmacol Drug Dev) - "Ertugliflozin and ertugliflozin/sitagliptin FDC tablets can be administered without regard to meals. As metformin is administered with meals because of its gastrointestinal side effects, the ertugliflozin/metformin FDC should also be administered with meals."

Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Fixed-dose combination of ertugliflozin and metformin hydrochloride for the treatment of type 2 diabetes. (PubMed, Expert Rev Endocrinol Metab) - "Given their favorable effects on glycemia control as well as 'extra-glycemic' parameters such as body weight and blood pressure, they are ideal agents for appropriate patients with type 2 diabetes. The fixed-dose combination of ertugliflozin with metformin is an effective combination that is conveniently administered and may improve medication adherence and persistence."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Drugs for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available.

Journal • Review

A PK/PD study comparing twice-daily to once-daily dosing regimens of ertugliflozin in healthy subjects. (PubMed, Int J Clin Pharmacol Ther) - "There are no clinically meaningful differences in steady-state PK or PD between ertugliflozin BID and QD regimens at total daily doses of 5 and 15 mg, supporting BID administration of ertugliflozin as a component of the ertugliflozin/metformin (immediate-release) FDC."

Clinical • Journal • PK/PD data

Bioequivalence of Ertugliflozin/Metformin Fixed-Dose Combination Tablets and Coadministration of Respective Strengths of Individual Components. (PubMed, Clin Pharmacol Drug Dev) - "The majority of adverse events were mild in intensity. The studies demonstrated that each strength of FDC tablet is bioequivalent to respective doses of coadministered individual components, supporting that safety and efficacy can be bridged to the individual components used in phase 3 studies evaluating ertugliflozin in combination with metformin."

Journal

Ertugliflozin for the treatment of type 2 diabetes. (PubMed, Drugs Today (Barc)) - "It was granted approval by the U.S. Food and Drug Administration (FDA) in December 2017 for treatment of T2DM as a monotherapy, and as part of two separate fixed-dose combination therapies with sitagliptin (Steglujan) and metformin (Segluromet). It also has a longer half-life (16.6 hours) than presently available gliflozins, which translates into single daily dosing and dose reduction allowing for patient compliance. This review will focus on the preclinical pharmacology, pharmacokinetics, clinical efficacy and safety of ertugliflozin."

Journal

Ertugliflozin for type 2 diabetes. (PubMed, Aust Prescr) - No abstract available.

Journal • Review