Kazano (alogliptin/metformin) / Takeda - LARVOL DELTA

Efficacy of Alogliptin/Metformin Fixed-Dose Combination Tablets and Vildagliptin/Metformin Fixed-Dose Combination Tablets on Glycemic Control in Real-World Clinical Practice for the Patients with Type 2 Diabetes: A Multicenter, Open-Label, Randomized, Parallel Group, Comparative Trial. (PubMed, Metab Syndr Relat Disord) - "No adverse events, such as severe hypoglycemia, were observed in either group. We concluded that there were no significant differences in the efficacy of two combination tablets of DPP-4 inhibitors and metformin with different dosages on glycemic control in patients with T2D."

Journal • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Thirteenth Annual Great Ladies Luncheon Symposium (YouTube) - "Dr. Kristine Yaffe...speak to their work on how lifestyle interventions, as well as the approved diabetes drug metformin, can help to delay or prevent Alzheimer's disease."

Video

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

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Different chromatographic methods for determination of alogliptin benzoate, metformin hydrochloride and metformin impurity in bulk and pharmaceutical dosage form. (PubMed, J Sep Sci) - "Two simple, sensitive and reproducible methods were developed for determination of alogliptin and metformin HCl in presence of metformin impurity "Melamin" in pure form and in pharmaceutical formulation. The proposed methods have been validated regarding accuracy, precision and selectivity, moreover they have been successfully applied to Westirizide tablets containing both Alogliptin and Metformin HCl, results indicate that there were no interference from additives. No significance difference was found when these methods were compared to the reported one."

Journal

"Badania: wykazano skuteczność leczenia uzupełniającego u pacjentów z czerniakiem z mutacją BRAF @sarcoma_pl @rutkowskip1972 @Novartis @GlosPacjenta #czerniak #badaniakliniczne #leczenie #melanoma #BRAF https://t.co/WUpdlEVEkK" (@MedicalpressPL)

Melanoma • Oncology • Sarcoma • Solid Tumor • BRAF

"Rozumiem czyli w Holandii w tym bardzo postępowym kraju gdzie dowiedziono naukowo że jednak nie zatrzymuje i gdzie kazano zaprzestania noszenia maseczek się pomylono tak bo co kurwa tam nie ma lekarzy tak jak w Polsce" (@Jan7376)

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

Durability of efficacy of monotherapy with sitagliptin in type 2 diabetic patients in Saitama district (SUCCEED Trial) (IDF 2017) - "...After initial 12 weeks, If those patients exhibited HbA1c values more than 7.4%, they gradually shifted from the initial therapy to the administration of sitagliptin by 100mg, metformin by 500-1500mg or pioglitazone by 15-30mg after plasma glucose check by every 8 week during 52 weeks...In ADOPT study the marked rebound phenominon of HbA1c after 5-year treatment was shown in order of glyburide, metformine and rosiglitazone, which report suggests the difference of durability among these diabetic drugs. In Endure study, the durability of the efficacy and safety of alogliptin was demonstrated compared to glipizide in type 2 diabetes mellitus for a 2-year study, therefore we were interested in the efficacy and durability of sitagliptin, instead of alogliptin.In conclusions, Three quarters of diabetic patients who reached the goal less than 7.4% of HbA1c in 12 weeks could maintain the appropriate HbA1c values without exacerbation and safety without any severe adverse events for 52.

Monotherapy • Diabetes

Efficacy and safety of fixed-dose combination therapy alogliptin plus metformin in Asian patients with type 2 diabetes: a phase 3 trial. (PubMed) - "The safety profile of alogliptin + metformin FDC was similar to the individual components alogliptin and metformin. The study demonstrated that treatment with alogliptin + metformin FDC BID resulted in better glycemic control than either monotherapy and was well tolerated in Asian patients with type 2 diabetes."

Journal • Biosimilar • Diabetes

Alogliptin plus metformin combination therapy vs alogliptin or metformin monotherapy for type 2 diabetes mellitus (EASD 2012) - Publication-only abstract; P3, N=784; NCT01023581; Greater reductions in proinsulin/insulin ratios and increases in HOMA-BCF (beta cell function) with ALO+MET vs ALO or MET monotherapy were observed; Modest weight decreases were observed with ALO+MET and MET, while ALO monotherapy was weight neutral; ALO & MET alone demonstrated the expected safety profiles, and the combination doses were well tolerated, having safety profiles similar to that of the monotherapy regimens; Overall, few subjects reported hypoglycemic events

P3 data • Diabetes

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 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

Takeda type 2 diabetes therapies, NESINA (alogliptin) and fixed-dose combinations KAZANO (alogliptin and metformin HCl) and OSENI (alogliptin and pioglitazone), are now available in pharmacies in the United States (Takeda) - "...announced that NESINA (alogliptin) and the fixed-dose combination therapies KAZANO (alogliptin and metformin HCl) and OSENI (alogliptin and pioglitazone) are now available by prescription in pharmacies in the United States..."

Launch US • Diabetes

Takeda announces acceptance of European Medicines Agency submissions for two fixed-dose combination therapies, alogliptin and pioglitazone and alogliptin and metformin, for the treatment of type 2 diabetes (Takeda) - Takeda announced that Takeda Global Research & Development Centre received confirmation of the acceptance of submissions of MAAs from the EMA for alogliptin and pioglitazone, which combines alogliptin with pioglitazone in a single tablet, and alogliptin and metformin, which combines alogliptin with metformin in a single tablet

CHMP / EMA regulatory • Diabetes

Takeda submits New Drug Application in the U.S. for investigational type 2 diabetes therapy, fixed-dose combination alogliptin/metformin (Takeda) - Takeda submitted a NDA to FDA for the fixed-dose combination therapy alogliptin/metformin, which combines alogliptin with metformin in a single tablet; The FDA is expected to review the NDA submission within the next ten months; Under Furiex's agreement with Takeda, this submission does not trigger a milestone payment to Furiex; Currently, Furiex receives royalty payments from Takeda for the sale of alogliptin products, trade names Nesina & Liovel, in Japan

NDA filing • Diabetes

Takeda: Q1 2013 Results (Takeda) - Anticipated EU approval of alogliptin+metformin combo for diabetes in FY 2013

Anticipated EU regulatory • Diabetes

EPIDOTE: A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by Alogliptin and Metformin Therapy (clinicaltrials.gov) - P4; N=232; Recruiting; Sponsor: Takeda; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

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

Journal • Review

"U petak imam zakazano kod dr Pavlović. Po preporuci kod njega. Laboratorija od jutros u redu je sve." (@ivanica111828)

Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age" (clinicaltrials.gov) - P=N/A; N=1027; Completed; Sponsor: Takeda; Active, not recruiting ➔ Completed

Clinical • Trial completion

EPIDOTE: A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by Alogliptin and Metformin Therapy (clinicaltrials.gov) - P4; N=232; Not yet recruiting; Sponsor: Takeda; N=176 ➔ 232; Trial completion date: Dec 2020 ➔ Jan 2022; Trial primary completion date: Jun 2020 ➔ Dec 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date

Alogliptin in Patients with Type 2 Diabetes on Metformin and Sulfonylurea Therapies in the EXAMINE Trial. (PubMed, Am J Med) - P3; "Addition of the DPP-4 inhibitor alogliptin to dual therapy with metformin plus sulfonylurea signficantly reduced HbA1c and was well tolerated. Lower mortality rates were seen in patients treated with alogliptin in this subgroup. CLINICALTRIALS."

Clinical • Journal

Comparison of the Effectiveness of Shockwave Therapy with Selected Physical Therapy Procedures in Patients with Tennis Elbow Syndrome. (PubMed, Ortop Traumatol Rehabil) - "...Wykazano większą krótkotrwałą skuteczność terapii z zastosowaniem radialnej fali uderzeniowej w porównaniu do laseroterapii i ultradźwięków w eliminowaniu bólu oraz poprawie funkcji kończyny górnej. 3. Fala uderzeniowa wydaje się być skuteczną terapią dla pacjentów z zespołem łokcia tenisisty, niemniej należy prowadzić dalsze badania dotyczące długotrwałych efektów prezentowanej metody leczenia."

Clinical • Journal

How to Streamline Cross-Continuum Data for Greater Usability (HIMSS 2019) - "Description: The Ohio Health Information Partnership’s (The Partnership) dynamic health information exchange (HIE), CliniSync, receives and communicates thousands of pieces of clinical information each day, working with hospitals, physician practices and other healthcare entities across the state...Discuss how to use HIE clinical information to drive population health efforts, including quality reporting and improving care management for high-risk patients. Describe methods for incorporating clinical advisory group feedback into a technology initiative, leveraging all viewpoints to meet strategic goals"