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

In vivo genotoxicity assessment of oral antidiabetic drugs in Drosophila melanogaster. (PubMed, J Toxicol Environ Health A) - "The aim of this study was to examine the genotoxic potential of empagliflozin, linagliptin, pioglitazone, and the fixed-dose combination (empagliflozin/linagliptin) using Somatic Mutation and Recombination Test (SMART) in Drosophila melanogaster. These findings suggest that while empagliflozin and linagliptin present no apparent detectable genotoxic hazard under these tested conditions, pioglitazone displays a dose-dependent genotoxic effect. Data indicate the importance of systematic genotoxicity assessment in widely used antidiabetic medications to ensure patient safety."

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

Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes (clinicaltrials.gov) - P4 | N=110 | Enrolling by invitation | Sponsor: Bahria University

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

Effectiveness and Safety of Fixed-Dose Empagliflozin/Linagliptin Combination in Type 2 Diabetes Mellitus: Real-World Evidence From Bangladesh. (PubMed, Cureus) - "In this real-world observational cohort of Bangladeshi adults with T2DM, treatment with the empagliflozin-linagliptin FDC was associated with improvements in glycemic control, cardiometabolic benefits, and renal improvements over 24 weeks, with a favorable short-term safety profile. These findings indicate that the FDC was associated with significant improvements in this real-world cohort, providing supportive evidence for its utility."

HEOR • Journal • Real-world evidence • Anorexia • Cardiovascular • Diabetes • Dyslipidemia • Hypoglycemia • Infectious Disease • Metabolic Disorders • Nephrology • Type 2 Diabetes Mellitus

Effectiveness of Empagliflozin-Linagliptin Fixed-Dose Combination on Chronic Kidney Disease Outcomes in Patients With Type 2 Diabetes in a Real-World Setting. (PubMed, Cureus) - " In this observational study, the use of FDC of empagliflozin and linagliptin for at least 12 months in T2DM patients previously uncontrolled on a DPP4-i-based regimen was associated with reductions in albuminuria and improvement in eGFR slope after the expected initial dip at three months. Improvements in glycemic control and body weight were also observed, regardless of underlying cardiometabolic risk. The potential renal benefits noted in this descriptive evidence warrant further evaluation."

Journal • Real-world evidence • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Diabetes • Hypertension • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Exploring the Real-World Effectiveness of Empagliflozin and Linagliptin Fixed-Dose Combination in Type 2 Diabetes Patients of Bangladesh: A Prospective Multi-Center Observational Study. (PubMed, Diabetes Metab Syndr Obes) - "The fixed-dose combination (FDC) of empagliflozin and linagliptin is a promising treatment for type 2 diabetes mellitus (T2DM), but real-world data from Bangladesh is limited. Empa/Lina (10/5) FDC demonstrated significant improvements in glycemic control, BMI, and blood pressure with a favorable safety profile in Bangladeshi patients with T2DM. These real-world findings support its use as an effective treatment option in this population."

Journal • Observational data • Real-world evidence • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Mycosis Fungoides • Nephrology • Type 2 Diabetes Mellitus

Triple arm, prospective, real-world study comparing the efficacy of FDC teneligliptin + dapagliflozin to FDC sitagliptin + dapagliflozin, and FDC linagliptin + empagliflozin in Indian type 2 diabetes mellitus patients using CGM device: the Amplify-TIR study. (PubMed, Cardiovasc Diabetol Endocrinol Rep) - No abstract available

Journal • Real-world evidence • 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

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

Trial completion • Diabetes • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Type 2 Diabetes Mellitus

To Compare and Evaluate the Oral Bioavailability of Empagliflozin + Linagliptin 10 mg/5 mg Filmcoated Tablets With That of Glyxambi 10 mg/ 5 mg Film-coated Tablets in Healthy, Adult, Human Subjects Under Fasting Conditions. (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Humanis Saglık Anonim Sirketi

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

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