Glyxambi (empagliflozin / linagliptin) / Boehringer Ingelheim, Eli Lilly - LARVOL DELTA

Bioequivalence Study to Compare Empagliflozin + Linagliptin 25 mg/5 mg Film-coated Tablets Versus Glyxambi 25 mg/ 5 mg Film-coated Tablets (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Humanis Saglık Anonim Sirketi

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

Triple-Arm, Prospective, Multicentre, Randomized, Open-Label, Active-Controlled Study to Assess Effect on FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg Compared with FDC of Sitagliptin 100 mg + Dapagliflozin 10 mg and FDC of Linagliptin 5 mg+ Empagliflozin 25 mg on 24-Hour Glucose . (ADA 2024) - "FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg, Sitagliptin 100 mg + Dapagliflozin 10 mg & FDC of Linagliptin 5 mg + Empagliflozin 25 mg had significant improvement in CGM & Glycemic parameters."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Presentation of glomerulocystic disease in a young onset diabetes: A case report. (PubMed, Medicine (Baltimore)) - "This case underscores the complexity of diagnosing and managing a young adult presenting with concurrent renal dysfunction, proteinuria, and diabetes mellitus in the absence of prior underlying conditions. It highlights the importance of comprehensive evaluation and ongoing care in such challenging cases."

Journal • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Genetic Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease

Innovative UV protocols based on straightforward mathematical filtration for concurrent estimation of two antidiabetic drugs in their brand-new combination: A comparative study. (PubMed, J AOAC Int) - "Two novel univariate methods were developed for quantitative analysis of linagliptin and empagliflozin in their pharmaceutical and lab mixtures, producing satisfactory results."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Bioequivalence Study of Empagliflozin And Linagliptin Tablets in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=106 | Completed | Sponsor: The Affiliated Hospital of Qingdao University

New P1 trial

Safety and Effectiveness of Empagliflozin/Linagliptin FDC in Uncontrolled T2DM Patients with COVID-19 Infection (ADA 2023) - "Once daily Empagliflozin/Linagliptin (25/5 mg) FDC was found to be safe, effective, and well tolerated in non-critically ill T2D patients with COVID-19 infection."

Clinical • Metabolic Disorders • Type 2 Diabetes Mellitus • IL6

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

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination therapy in Japanese patients with type 2 diabetes: final results of a one-year post-marketing surveillance study. (PubMed, Expert Opin Drug Saf) - P=N/A | "Empagliflozin/linagliptin FDC was effective and generally well tolerated in Japanese patients with T2D; no new safety concerns were identified. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT03761797)."

Combination therapy • Journal • P4 data • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Nephrology • Type 2 Diabetes Mellitus

Inventiva announces the screening of the first patient in LEGEND, a Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and T2D (GlobeNewswire) - P2 | N=63 | LEGEND (NCT05232071) | Sponsor: Inventiva Pharma | "Prof. Michelle Lai...LEGEND Phase IIa clinical trial, said: 'The LEGEND trial is expected to help us better understand the pathophysiology of patients we care for in our clinics who suffer of NASH and T2D. Insulin resistance is a root cause leading to the development of NASH, and the combination of lanifibranor and empagliflozin could potentially provide complementary effects and provide additional therapeutic benefits to improve the overall cardiometabolic health of our patients.'"

Enrollment open • Media quote • P2a data

Rationality, Efficacy, Tolerability of Empagliflozin plus Linagliptin Combination for the Management of Type 2 Diabetes Mellitus: A Systematic review of randomized controlled trials and observational studies. (PubMed, Curr Diabetes Rev) - "After reviewing findings from the available clinical studies of the combination of empagliflozin plus linagliptin we conclude that, the combination is effective, safe, tolerable and rationale cost effective combination compared to placebo and either drug alone for the management of T2DM in patients with inadequate glycemic control with metformin alone, patients with intoleratance to metformin, increased baseline HbA1c, patients with overweight or obesity and diabetic hypertensive, CHF, atherosclerotic cardiovascular disease and renal dysfunction patients. We suggest for more number of future randomized controlled studies in more number of T2DM patients with or without CHF and renal failure patients."

Clinical • Journal • Observational data • Review • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes (clinicaltrials.gov) - P=N/A; N=1164; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting ➔ Completed

Adverse events • Clinical • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

GOLDEN-AGE: GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial (clinicaltrials.gov) - P4; N=1167; Not yet recruiting; Sponsor: Center for Outcomes Research and Clinical Epidemiology, Italy

Clinical • New P4 trial • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Determination of linagliptin and empagliflozin by UPLC and HPTLC techniques aided by Lean Six Sigma approach. (PubMed, Biomed Chromatogr) - "The R were found to be 0.29 and 0.53 for linagliptin and empagliflozin respectively. All variables were investigated to adjust the whole conditions."

Journal

UTI-flog: SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections. (clinicaltrials.gov) - P; N=60; Recruiting; Sponsor: University of Pisa

New trial • Diabetes • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Type 2 Diabetes Mellitus

47 price changes [Google translation] (PharmaStar) - "GLYXAMBI 30 cpr rev 10 mg + 5 mg: BOEHRINGER INGELHEIM AIC: 045183050 € 106.49 from: 01/01/2021 class: A old price: € 101.17 GLYXAMBI 30 cpr rev 25 mg + 5 mg BOEHRINGER INGELHEIM AIC: 045183148 € 106.49 from: 01/01 / 2021 class: A previous price: € 101.17...OZEMPIC 1 pre-filled pen 1.5 ml 0.25 mg / dose + 4 NOVO NORDISK needles AIC: 046128029 € 177.71 from: 01/01/2021 class: A old price: € 168.82....VICTOZA 2 pre-filled pens SC 3 ml 6 mg / ml NOVO NORDISK AIC: 039365010 € 131.82 from: 01/01/2021 class: A old price: € 138.76."

Pricing • Diabetes • Type 2 Diabetes Mellitus

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

Journal

Stability Indicating UPLC method Development and Validation for Simultaneous estimation of Metformin, Linagliptinin Empagliflozin and in Bulk and Pharmaceutical Dosage Form. (PubMed, Biomed Chromatogr) - "The performance of the proposed method was compared with reported RP-UPLC methods and found to be rapid and economical. The developed and validated stability-indicating RP-UPLC method was appropriate for the quality control and drug analysis."

Journal

RACELINES: Renal Actions of Combined Empagliflozin and LINagliptin in Type 2 diabetES (clinicaltrials.gov) - P4; N=66; Recruiting; Sponsor: M.H.H. Kramer; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Single-pill Combination of Empagliflozin and Linagliptin in Real World Indian Type 2 Diabetes Patient (GRID). (PubMed, J Assoc Physicians India) - "This real-world evidence complements the results observed in randomized controlled trials, for meaningful effectiveness with the use of empagliflozin-linagliptin fixed dose combination in the Indian outpatient setting. More evidence may facilitate further characterization of clinical value of this promising combination."

Clinical • Journal • Real-World Evidence • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

[VIRTUAL] Empagliflozin, either alone or in combination with linagliptin, restores autophagy and apoptosis regulators in the kidney in db/db diabetic mice (EASD 2020) - "Materials and Male 8-week-old db/db mice (BKS.Cg-Dock7 m +/+Lepr db /J) were treated by vehicle, empagliflozin (10 mg/kg) or combination of empagliflozin and linagliptin (10 mg/kg of each) for 8 weeks... The data demonstrate that empagliflozin, either alone or in combination with linagliptin, restores autophagy and suppresses apoptosis in the kidney in a model of type 2 diabetes. These effects could contribute to preservation of glomerular structure and mitigation of podocyte injury. The data provide further explanation of renal protective effect of SGLT-2 and DPP-4 inhibitors in diabetes."

Combination therapy • IO Biomarker • Preclinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • BCL2 • CASP3 • LEP

In brief: Trijardy XR - a new 3-drug combination for Type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparison of efficacy and safety of empagliflozin vs linagliptin added to premixed insulin in patients with uncontrolled type 2 diabetes: a randomized, open-label study. (PubMed, Diabetes Metab) - "In Asian patients with inadequately controlled T2DM while taking premixed insulin, the addition of empagliflozin for 24 weeks provided better glycaemic control and greater reductions in body weight and systolic blood pressure than the addition of linagliptin."

Clinical • Journal • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Nephrology • Type 2 Diabetes Mellitus

Antidiabetic agents and cardiovascular outcomes in patients with heart diseases. (PubMed) - Curr Med Res Opin - "Peer-reviewed articles were identified from MEDLINE and Current Content database (both 1966 to October 1, 2016) using the search terms insulin, metformin, rosiglitazone, pioglitazone, glyburide, glipizide, glimepiride, acarbose, miglitol, albiglutide, exenatide, liraglutide, lixisenatide, dulaglutide, pramlintide, meglitinide, alogliptin, linagliptin, saxagliptin, sitagliptin, canagliflozin, dapagliflozin, empagliflozin, colesevalam, bromocriptine, mortality, myocardial infarction (MI), heart failure, (HF) and stroke. However, these trials have placebo-controlled, non-inferiority designs aiming to show absence of CV toxicity. More studies are needed to address other questions, including comparative effectiveness, and longer term risk versus benefits."

Journal • Acute Coronary Syndrome • Biosimilar • Cardiovascular • Diabetes • Heart Failure

Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes. (PubMed, Postgrad Med) - "The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations. Based on these two bioequivalence studies and existing phase 3 data, the FDA has recently approved this triple FDC to improve glycemic control in adults with T2D."

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

[VIRTUAL] Efficacy of Fixed-Dose Combination of Empagliflozin and Linagliptin in Addition to the Ongoing Treatment in Type 2 Diabetes: Real-World Observational Study (ADA 2020) - "The ongoing treatment in 20% (n=100), 43% (n=214), 38% (n=189), 26% (n=127) were metformin (M), combination of M and sulfonylureas (SU), combination of M, SU and voglibose, and insulin, respectively. There was a meaningful change and a substantial quantum of improvement in glycemic, metabolic and renal parameters. The results need to be validated through a long-term larger study."

Clinical • Observational data • Real-World Evidence • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus