linagliptin/metformin / Generic mfg. - LARVOL DELTA

Reduction in the Risk of Peripheral Neuropathy and Preservation of Kidney Function with Metformin, Linagliptin, or Their Fixed-Dose Combination, Compared with Placebo in Prediabetes—A Randomized Controlled Trial (ADA 2023) - "Objective: To compare the effect of glucose-lowering drugs plus lifestyle modification with lifestyle alone on peripheral nerve and kidney function in people with prediabetes. Multicenter, randomized, placebo-controlled trial in 658 individuals aged 45-74 years with prediabetes (IFG or IGT), were randomized to either metformin monotherapy, linagliptin monotherapy, fixed-dose combination of linagliptin/metformin or masked placebo. In people with prediabetes, 1-year treatment with metformin and linagliptin, combined or in monotherapy, was associated with a lower risk of SFPN, and with a better preservation of kidney function than with placebo."

Clinical • Metabolic Disorders

"@Boehringer why is Trajenta Duo 2.5/500 out of stock in Indian markets ?" (@kejriwal_ritu)

DIA_CENTRAL:T2D Treatment Pattern in Central Europe (clinicaltrials.gov) - P=N/A; N=3735; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting ➔ Completed

Clinical • Real-world evidence • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Drugs for diabetics and sedatives present a shortage in the entity [Google translation] - "Midazolam, Propofol, Enaxoparin, Trayenta duo and Atorvastatin are the drugs that are in short supply in some private pharmacies....'It is not only in the private sector, but also in public pharmacies in hospitals or clinics, it is a shortage in general. This is because pharmaceutical companies are stopping production to focus on drugs to treat Covid,'..."

Commercial • CNS Disorders • Pain • Renal Disease • Type 2 Diabetes Mellitus

[VIRTUAL] Incidence of diabetic patients with ASCVD or Heart Failure on DPP4s and candidates for GLP-1 agonists or SGLT-2s for improved cardiovascular outcomes and reduced cost (ASHP 2020) - " Retrospective EMR Review (EPIC) Population: Patients with Type 2 Diabetes Mellitus with additional comorbidities of ASCVD or HF currently on therapy of DPP4 inhibitor Inclusion Criteria: Patients ≥ 18 years of age Patients with uncontrolled Type 2 Diabetes Mellitus + ASCVD or HF Patients on therapy of DPP4 Inhibitor Exclusion Criteria (based on chart review): Pregnancy Previous Failure of GLP-1 in patients with ASCVD Previous Failure of SGLT-2 inhibitors in patients with heart failure Patients on hemodialysis or continuous renal replacement therapy (CRRT) Patients with eGFR < 30 mL/min in patients with heart failure Patients with significant history of urinary tract infections (3+/year) in patients with heart failure History of pancreatitis in patients with ASCVD History of medullary thyroid carcinoma (MTC) in patients with ASCVD Patients with multiple endocrine neoplasia syndrome type 2 (MEN2) in patients with ASCVD Data Collection: Patient Demographics: Sex Age..."

Clinical • Allergy • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Oncology • Pancreatitis • Renal Disease • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma • Type 2 Diabetes Mellitus

[VIRTUAL] Using diabetes disease state management interventions to improve the patient assistance program application process during a pandemic at a charity clinic (ASHP 2020) - "The DPP-4 inhibitors included in the study were Januvia, Janumet, Tradjenta, and Jentadueto. Creating a process improvement plan that allows patients to receive the appropriate medications during the pandemic helps to improve patient outcomes and ensure patient safety. Scheduling patients to be seen in DSM and facilitating the application process removes barriers related to adherence and risk of complications. Further follow up can be done to ensure these patients received the benefit of the DSM intervention."

Clinical • Diabetes • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease

"In #CDMX, Trayenta Duo is out..." (@profpga)

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

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

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

Journal • Biosimilar • Diabetes

Effects of sequentially adding empagliflozin and linagliptin on alpha and beta cell function in type 2 diabetic patients on previous metformin treatment - An exploratory mechanistic study. (PubMed) - "After metformin failure, sequential treatment escalation with empagliflozin and linagliptin is an attractive treatment option because of the additive effects on postprandial glucose control, probably mediated by complementary effects on α- and β-cell function."

Journal • Biosimilar • Diabetes

This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Boehringer Ingelheim

New P1 trial • Biosimilar

Which Is Better? High-Dose Metformin Alone or Combination of Low-Dose Metformin and Linagliptin on Glycemic Variability in Japanese Type 2 Diabetes Patients with Insufficient Glycemic Control with Low-Dose Metformin Alone - A Randomized, . (ADA 2018) - "Again, while the pre-breakfast glucose level were not significantly different between the groups (p=0.432), the AUC after breakfast was significantly smaller in LMET+DPP-4 vs. HMET (5004 ± 3220 vs. 7712 ± 5177; p=0.047). A comparison of GV with HMET vs. LMET+DPP-4 suggested that LMET+DPP-4 may reduce post-breakfast GV to a greater degree than HMET in Japanese patients with T2D receiving low dose metformin monotherapy."

Clinical • Biosimilar • Diabetes

The Effect of Linagliptin versus Metformin Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus. (PubMed, Diabetes Ther) - "We did not find significantly better treatment-related QOL with linagliptin among Japanese patients with T2DM. In terms of treatment convenience, our data showed that linagliptin was superior to metformin."

Clinical • HEOR • Journal • Biosimilar • Diabetes • Metabolic Disorders

DIA_CENTRAL:T2D Treatment Pattern in Central Europe (clinicaltrials.gov) - P=N/A; N=4000; Active, not recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: May 2020 ➔ Jan 2021; Trial primary completion date: May 2020 ➔ Jan 2021

Clinical • Real-World Evidence • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

FDA approves Jentadueto (linagliptin/metformin hydrochloride) tablets for the treatment of adult patients with type 2 diabetes (Boehringer Ingelheim) - FDA has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin; Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for adults with type 2 diabetes who need to improve control of their blood glucose

FDA approval • Diabetes

Boehringer Ingelheim and Lilly's new oral type 2 diabetes treatment for adults, Jentadueto (linagliptin/metformin hydrochloride) tablets, now available in U.S. pharmacies (PRNewswire) - Boehringer Ingelheim and Eli Lilly and Company today announced Jentadueto (linagliptin/metformin hydrochloride) tablets are now available by prescription in many leading chain and independent pharmacies across the US

Market launch • Diabetes

Jentadueto (linagliptin/metformin hydrochloride) tablets receive approval for the treatment of adults with type 2 diabetes in Europe (Boehringer Ingelheim) - Boehringer Ingelheim and Eli Lilly received marketing authorisation from the European Commission for Jentadueto which combines the DPP-4 inhibitor, linagliptin and metformin in a single tablet

European regulatory • Diabetes

Jentadueto diabetes pill launched in the UK (Diabetes.co.uk) - "A new drug treatment for type 2 diabetes that combines metformin with the DPP-4 inhibitor linagliptin in a single tablet is now available in the UK"

Launch Europe • Diabetes

Initial combination of linagliptin and metformin improves glycaemic control in type 2 diabetes: A randomized, double-blind, placebo-controlled study (community.diabetes.org) - P3, N=791; The placebo-corrected mean (95% confidence interval) change in HbA1c from baseline (8.7%) to week 24 was −1.7% (−2.0, −1.4) for linagliptin + high-dose metformin, −1.3% (−1.6, −1.1) for linagliptin + low-dose metformin, −1.2% (−1.5, −0.9) for high-dose metformin, −0.8% (−1.0, −0.5) for low-dose metformin and −0.6 (−0.9, −0.3) for linagliptin

P3 data • Diabetes

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

Journal • Review

Combination Therapy of Empagliflozin and Linagliptin vs. Metformin and Insulin Glargine on Intra- and Renal Hemodynamics in Type 2 Diabetes (KIDNEY WEEK 2019) - "Analysis of intrarenal hemodynamics identified different underlying hemodynamic mechanism, with E+L (surprisingly) mainly decreasing RE and M+I affecting RA. Funding Commercial Support"

Combination therapy

Effect of Low Dose Combination of Linagliptin + Metformin to Prevent Diabetes (clinicaltrials.gov) - P3; N=34; Recruiting; Sponsor: Universidad de Guanajuato

Clinical • New P3 trial

Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes (clinicaltrials.gov) - P3; N=34; Recruiting; Sponsor: Universidad de Guanajuato

Clinical • New P3 trial

Which is better, high-dose metformin monotherapy or low-dose metformin/ linagliptin combination therapy, in improving glycemic variability in type 2 diabetes patients with insufficient glycemic control despite low-dose metformin monotherapy: A randomized, crossover, CGM-based, pilot study. (PubMed, J Diabetes Investig) - "A comparison of GV with HMET versus LMET + DPP4 suggested that LMET + DPP4 might reduce post-breakfast GV to a greater degree than HMET in type 2 diabetes patients receiving low-dose metformin monotherapy."

Clinical • Combination therapy • Journal • Monotherapy