Liovel (alogliptin/pioglitazone) / Takeda - LARVOL DELTA

Fixed-dose combinations of hypoglycemic drugs: potential of alogliptin/pioglitazone in type 2 diabetes mellitus: a review (PubMed, Ter Arkh) - "Alogliptin and pioglitazone are of interest in terms of their complex effect on the patient's organism. The purpose of this review is to assess the advantages of the combination of alogliptin and pioglitazone based on an analysis of published data on the pharmacodynamics, pharmacokinetics, efficacy and safety of these drugs."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Decoding the synergy: unveiling gradient boosting regression model for multivariate quantitation of pioglitazone, alogliptin and glimepiride in pure and tablet dosage forms. (PubMed, BMC Chem) - "In the case of GLM, XG Boost also excelled with an RMSEP of 0.001 and SD of 0.018, demonstrating superior precision compared to the much higher errors seen in PLS and ANN. These results highlight XG Boost's exceptional ability to handle complex, overlapping spectral data, making it the most reliable and accurate model in this study."

Journal

Efficacy and Safety of Alogliptin-Pioglitazone Combination for Type 2 Diabetes Mellitus Poorly Controlled with Metformin: A Multicenter, Double-Blind Randomized Trial. (PubMed, Diabetes Metab J) - "Early combination triple therapy showed better efficacy and durability than the single add-on (dual) therapy. Therefore, combination therapy with metformin, alogliptin, and pioglitazone is a valuable early treatment option for T2DM poorly controlled with metformin monotherapy."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

COMBINATION OF PIOGLITAZONE AND ALOGLIPTIN IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS (ATTD 2024) - "Thus, the combination of Pioglitazone and Alogliptin seems to be clinically effective, as it affects several links in the pathogenesis of diabetes mellitus at once."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • PPARG

EPIDOTE: A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy (clinicaltrials.gov) - P4 | N=133 | Active, not recruiting | Sponsor: Celltrion Pharm, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2023 ➔ Jun 2024 | Trial primary completion date: Jan 2023 ➔ Jan 2024

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

Earth-friendly micellar UPLC technique for determination of four hypoglycemic drugs in different pharmaceutical dosage forms and spiked human plasma. (PubMed, BMC Chem) - "A novel, sensitive, and green micellar UPLC method was proposed and validated for the simultaneous determination of four hypoglycemic agents used in type II diabetes mellitus treatment namely, pioglitazone, alogliptin, glimepiride, and vildagliptin. The method was found to be efficiently applicable in spiked human plasma and could be extended to study the pharmacokinetics of the cited drugs in real human plasma samples. The greenness of the developed method was evaluated by applying the Eco-scale scoring tool, which verified the excellent greenness of the analytical method."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Against the motion (ESTRO 2023) - "Hafeez S, Webster A, Hansen VN, McNair HA, Warren-Oseni K, Patel E, et al...2021 Dec; 20:54-60. doi:10.1016/j.tipsro.2021.11.001."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

"Congratulations to you Dr Oseni" (@Bibitsvet)

An Effective Chromatographic Method for Simultaneous Quantification of Antidiabetic Drugs Alogliptin Benzoate and Pioglitazone HCl in Their Tablet Dosage Form: Implementation to In vitro Dissolution Studies and Uniformity of Dosage Unit. (PubMed, J Chromatogr Sci) - "In patients with Type 2 diabetes, a combination of Alogliptin and Pioglitazone medications, together with diet and physical activity, are used to improve glycemic control. The metrics of the designed method were assessed according to ICH requirements, and all metrics, such as system suitability, linearity, recovery, robustness, LOD, LOQ, specificity and precision, were found to be within required tolerances and no overlapping was found for degradation peaks. Thence, the method can be used in quality control for the analysis of raw material, bulk, finish and stability."

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

EPIDOTE: A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy (clinicaltrials.gov) - P4 | N=156 | Recruiting | Sponsor: Celltrion Pharm, Inc. | Trial completion date: Apr 2023 ➔ Jul 2023

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

EPIDOTE: A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy (clinicaltrials.gov) - P4 | N=156 | Recruiting | Sponsor: Celltrion Pharm, Inc. | N=232 ➔ 156 | Trial completion date: Feb 2022 ➔ Apr 2023 | Trial primary completion date: Jan 2022 ➔ Jan 2023

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

Comparison of Efficacy of Glimepiride, Alogliptin, and Alogliptin-Pioglitazone as the Initial Periods of Therapy in Patients with Poorly Controlled Type 2 Diabetes Mellitus: An Open-Label, Multicenter, Randomized, Controlled Study. (PubMed, Diabetes Metab J) - "The choice of an optimal oral hypoglycemic agent in the initial treatment periods for type 2 diabetes mellitus (T2DM) patients remains difficult and deliberate. The adverse events were similar among the three arms. ALO-PIO combination therapy during the early period exerts better glycemic control than ALO monotherapy and excellency in glycemic variability than low-dose sulfonylurea therapy in uncontrolled, drug-naïve or metformin failed T2DM patients."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

An overview of alogliptin + pioglitazone for the treatment of type 2 diabetes. (PubMed, Expert Opin Pharmacother) - "It does not appear to increase the adverse events associated with pioglitazone and use of the combination may permit the use of lower doses of pioglitazone with reduced adverse effects. There are no cardiovascular outcome studies with the combination but the cardiovascular benefits of pioglitazone and additional glucose lowering effects of alogliptin provide a useful combination with convenient once daily dosing."

Journal • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Musculoskeletal Diseases • Orthopedics • Type 2 Diabetes Mellitus • PPARG

A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea (clinicaltrials.gov) - P; N=730; Completed; Sponsor: Takeda

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

Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination (clinicaltrials.gov) - P4; N=99; Active, not recruiting; Sponsor: Seoul National University Hospital; Trial completion date: Aug 2020 ➔ Aug 2021

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

To Evaluate the Effect of Nesinaact on Non-alcoholic Steatohepatitis Through MRI and Liver Fibroscan in Patients With Type 2 Diabetes (clinicaltrials.gov) - P4; N=60; Recruiting; Sponsor: Yonsei University; Not yet recruiting ➔ Recruiting; Trial primary completion date: Jun 2020 ➔ Dec 2020

Clinical • Enrollment open • Trial primary completion date • Diabetes • Hepatology • Metabolic Disorders • Non-alcoholic Steatohepatitis • Type 2 Diabetes Mellitus

INF-DM2-Ther: Anti-inflammatory Status in DM2 Treated Patients (clinicaltrials.gov) - P4; N=36; Recruiting; Sponsor: University of Catanzaro; Not yet recruiting ➔ Recruiting; Trial completion date: Dec 2020 ➔ Jun 2021

Clinical • Enrollment open • Trial completion date • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

INF-DM2-Ther: Anti-inflammatory Status in DM2 Treated Patients (clinicaltrials.gov) - P4; N=36; Not yet recruiting; Sponsor: University of Catanzaro

Clinical • New P4 trial • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination (clinicaltrials.gov) - P4; N=99; Active, not recruiting; Sponsor: Seoul National University Hospital

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

"Thank you for the answer, I understand that in Europe Incresina P is marketed as Incresync, Am i wrong, is it marketed in France, please recommend a physician near Gorcy, France." (@josepareyon)

Takeda receives positive CHMP opinion for three new type 2 diabetes therapies, Vipidia (alogliptin) and fixed - dose combinations Vipdomet (alogliptin - metformin) and Incresync (alogliptin - pioglitazone) (Takeda Press Release) - “...Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a positive opinion for Vipidia TM (alogliptin), a dipeptidyl peptidase IV (DPP - 4) inhibitor, and for the fixed dose combination (FDC) therapies Vipdomet TM (alogliptin - metformin) and Incresync TM (alogliptin - pioglitazone)...based on...the one year data from the ENDURE * trial and interim data from the cardiovascular outcomes trial EXAMINE"

European regulatory • Diabetes

Takeda resubmits New Drug Applications to the United States Food and Drug Administration for alogliptin and the fixed-dose combination alogliptin and pioglitazone (PRNewswire) - Takeda announced that its wholly-owned subsidiary, Takeda Global Research & Development Center, resubmitted NDAs to the US FDA for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone; Takeda anticipates that these applications will be reviewed within the next six months; This 2012 resubmission includes additional data from three P3 clinical trials involving more than 3,275 pts conducted at 1,384 centers worldwide

NDA • Diabetes

Takeda receives simultaneous European Marketing Authorization for three new type 2 diabetes therapies, Vipidia TM (alogliptin) and fixed - dose combinations Vipdomet TM (alogliptin and metformin) and Incresync TM (alogliptin and pioglitazone) (Takeda) - “... European Commission has granted Marketing Authorization (MA) for Vipidia TM ( alogliptin), a dipeptidyl peptidase IV (DPP - 4) inhibitor, for the treatment of type 2 diabetes patients who are uncontrolled on existing therapies 1 - 3 and for the fixed - dose combination (FDC) therapies Vipdomet TM (alogliptin with metformin) and Incresync TM ( alogliptin with pioglitazone).”

European regulatory • Diabetes

Takeda receives FDA approval for three new type 2 diabetes therapies,NESINA (alogliptin) and fixed-dose combinations OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) (Takeda) - "...has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise...is planning to commercially launch NESINA, OSENI and KAZANO in the summer of 2013."

Anticipated launch US • NDA • Diabetes