[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of saxagliptin tablets in Chinese healthy subjects under fasting and fed conditions

主要研究目的：以AstraZeneca AB持证的沙格列汀片（规格：5 mg，商品名：安立泽/ONGLYZA）为参比制剂，以浙江杭康药业有限公司生产的沙格列汀片（规格：5 mg）为受试制剂，通过单中心、单次给药、随机、开放、两周期、双交叉设计的临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to use AstraZeneca AB's licensed saxagliptin tablets (specification: 5 mg, trade name: ONGLYZA) as the reference preparation and Zhejiang Hangkang Pharmaceutical Co., Ltd.'s saxagliptin tablets (specification: 5 mg) as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and fed state through a single-center, single-dose, randomized, open, two-period, double-crossover clinical study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date22 Jan 2024

Sponsor / Collaborator

Zhejiang Hangkang Pharmaceutical Co Ltd.

NCT05347459 / RecruitingNot ApplicableIIT

Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients

The proposed study aims to:
Explore the cognitive protective effects of SGLT2 inhibitors and DPP-4 inhibitors in patients attending diabetic clinics in Alexandria
Examine the possible relationship of such effects with the systemic inflammatory and metabolic status in these patients
Undertake a network analysis to elucidate the potential pathways linking the observed protective effects, if any, with the observed changes in inflammatory or metabolic parameters

Start Date02 Mar 2022

Sponsor / Collaborator

Alexandria University

NCT05073692 / RecruitingNot Applicable

Comparison of Type 2 Diabetes Pharmacotherapy Regimens Using Targeted Learning

This study is designed to help patients with type 2 diabetes and their clinicians: (a) identify which glucose lowering medications have the most favorable effects on heart health and other patient-important outcomes, (b) inform the timing of medication initiation, and (c) identify whether medication benefits apply equally to all adults with type 2 diabetes, or may be different based on age, sex, race/ethnicity, baseline heart health status, baseline renal function, or other factors.

Start Date01 Jul 2021

Sponsor / Collaborator

Kaiser Permanente, Inc.

[+4]

100 Clinical Results associated with Saxagliptin Hydrate

100 Translational Medicine associated with Saxagliptin Hydrate

100 Patents (Medical) associated with Saxagliptin Hydrate

781

Literatures (Medical) associated with Saxagliptin Hydrate

01 May 2024·Diabetes, obesity & metabolism

Saxagliptin/dapagliflozin is non‐inferior to insulin glargine in terms of β‐cell function in subjects with latent autoimmune diabetes in adults: A 12‐month, randomized, comparator‐controlled pilot study

Article

Author: Pozzilli, Paolo ; Fogolari, Marta ; Naciu, Anda M ; Buzzetti, Raffaella ; Mignogna, Carmen ; Sasso, Ferdinando Carlo ; Angeletti, Silvia ; Maddaloni, Ernesto ; Amendolara, Rocco ; Galiero, Raffaele ; Serafini, Chiara ; Cossu, Efisio ; Satta, Chiara ; Cavallo, Maria Gisella

Abstract:

Aim:

To compare the efficacy and safety of saxagliptin/dapagliflozin and insulin glargine in people with latent autoimmune diabetes in adults (LADA).

Methods:

In this phase 2b multicentre, open‐label, comparator‐controlled, parallel‐group, non‐inferiority study, we randomly assigned 33 people with LADA who had a fasting C‐peptide concentration ≥0.2 nmol/L (0.6 ng/mL) to receive 1‐year daily treatment with either the combination of saxagliptin (5 mg) plus dapagliflozin (10 mg) or insulin glargine (starting dose: 10 IU), both on top of metformin. The primary outcome was the 2‐h mixed meal‐stimulated C‐peptide area under the curve (AUC), measured 12 months after randomization. Secondary outcomes were glycated haemoglobin (HbA1c) levels, change in body mass index (BMI), and hypoglycaemic events.

Results:

In the modified intention‐to‐treat analysis, the primary outcome was similar in participants assigned to saxagliptin/dapagliflozin or to insulin glargine (median C‐peptide AUC: 152.0 ng*min/mL [95% confidence interval {CI} 68.2; 357.4] vs. 122.2 ng*min/mL [95% CI 84.3; 255.8]; p for noninferiority = 0.0087). Participants randomized to saxagliptin/dapagliflozin lost more weight than those randomized to insulin glargine (median BMI change at the end of the study: −0.4 kg/m2 [95% CI −1.6; −0.3] vs. +0.4 kg/m2 [95% CI −0.3; +1.1]; p = 0.0076). No differences in HbA1c or in the number of participants experiencing hypoglycaemic events were found.

Conclusions:

Saxagliptin/dapagliflozin was non‐inferior to glargine in terms of β‐cell function in this 12‐month, small, phase 2b study, enrolling people with LADA with still viable endogenous insulin production. Weight loss was greater with saxagliptin/dapagliflozin, with no differences in glycaemic control or hypoglycaemic risk.

01 Dec 2023·Biopharmaceutics & drug disposition

Influence of Gegenqinlian decoction on pharmacokinetics and pharmacodynamics of saxagliptin in type 2 diabetes mellitus rats

Article

Author: Cui, Mingyu ; Yin, Yifeng ; Gai, Yingli ; Yan, Xueying ; Yu, Chao ; Sui, Yue ; Zhu, Fengmei

Abstract:

Gegenqinlian decoction (GQD) is a classic prescription of traditional Chinese medicine (TCM), which originated from Shanghanlun. The combination of GQD and hypoglycemic drugs (saxagliptin, Sax, metformin) is often used to treat Type 2 diabetes mellitus (T2DM) in TCM clinics. However, the herb–drug interactions (HDIs) between GQD and hypoglycemic drugs are still unclear. In order to determine the safety of the combination, we assessed the influences of GQD on the pharmacokinetics and pharmacodynamics of Sax in T2DM rats. The plasma concentration of Sax (5 mg/kg) pretreated with GQD (freeze‐dried powder, 1.35 g/kg) or not was determined by high‐performance liquid chromatography (HPLC), and pharmacokinetics parameters were calculated. The influence of GQD on the pharmacodynamics of Sax was investigated by detecting the levels of weight, (see abbreviations list) OGTT, TC, TG, LDL‐C, HDL‐C, FBG, FINS, HOMA‐IR, QUICKI, AST, ALT, and the liver coefficient. The Cmax, AUC0‐t,and AUC0‐∞ of Sax increased significantly in the combination group whether in normal or T2DM rats. The results of pharmacodynamics showed that the weight of rats in each treatment group increased. FBG, TC, TG, LDL‐C, and HOMA‐IR decreased, HDL‐C, FINS, and QUICKI increased significantly (p < 0.05) compared with the model control group. The result showed that the combination of GQD and Sax could not only improve the hypoglycemic effect but also increase the plasma exposure of Sax. The potential HDIs between GQD and Sax should be taken into consideration in clinics. Moreover, for the complexity of the human compared with experimental animals, as well as genetic differences, the in‐depth study should be carried out to assess the uniformity of the pharmacokinetics and pharmacodynamics between rats and humans.

01 Nov 2023·Mutation research. Genetic toxicology and environmental mutagenesis

Saxagliptin, a selective dipeptidyl peptidase-4 inhibitor, alleviates somatic cell aneugenicity and clastogenicity in diabetic mice

Article

Author: Bakheet, Saleh A ; Ansari, Mushtaq A ; Alshamrani, Ali A ; Ashour, Abdelkader E ; Nadeem, Ahmed ; Ahmad, Sheikh F ; Attia, Sabry M ; Attia, Mohamed S M ; Albekairi, Norah A ; Al-Hamamah, Mohammed A

Diabetes-related complications are becoming increasingly common as the global prevalence of diabetes increases. Diabetes is also linked to a high risk of developing cancer. This raises the question of whether cancer vulnerability is caused by diabetes itself or the use of antidiabetic drugs. Chromosomal instability, a source of genetic modification involving either an altered chromosomal number or structure, is a hallmark of cancer. Saxagliptin has been approved by the FDA for diabetes treatment. However, the detailed in vivo effects of prolonged saxagliptin treatment on chromosomal instability have not yet been reported. In this study, streptozotocin was used to induce diabetes in mice, and both diabetic and non-diabetic mice received saxagliptin for five weeks. Fluorescence in situ hybridization was conducted in combination with a bone marrow micronucleus test for measuring chromosomal instability. Our results indicated that saxagliptin is neither mutagenic nor cytotoxic, under the given treatment regimen. Diabetic mice had a much higher incidence of micronuclei formation, and a centromeric DNA probe was present inside the majority of the induced micronuclei, indicating that most of these were caused by chromosome nondisjunction. Conversely, diabetic mice treated with saxagliptin exhibited a significant decrease in micronuclei induction, which were centromeric-positive and centromeric-negative. Diabetes also causes significant biochemical changes indicative of oxidative stress, such as increased lipid peroxidation and decreased reduced/oxidized glutathione ratio, which was reversed by saxagliptin administration. Overall, saxagliptin, the non-mutagenic antidiabetic drug, maintains chromosomal integrity in diabetes and reduces micronuclei formation by restoring redox imbalance, further indicating its usefulness in diabetic patients.

News (Medical) associated with Saxagliptin Hydrate

13 Jun 2024

·www.pharmaceutical-technology.com

FDA approves AstraZeneca’s Farxiga for paediatric T2D patients

Trial results showed a significant decrease in A1C for patients treated with Farxiga versus those given a placebo. Credit: Studio Romantic / Shutterstock. The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ‘s Farxiga (dapagliflozin) for the treatment of paediatric patients aged 10 years and above with type-2 diabetes (T2D) Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems The approval is a significant milestone, expanding the medication’s use to improve glycaemic control in children beyond its previous adult-only indication. The FDA’s decision was based on the randomised, double-blind, placebo-controlled T2NOW Phase III trial. The study assessed the efficacy and safety of dapagliflozin as an additional treatment for children and adolescents already taking metformin, insulin or both. Participants were assigned to receive either dapagliflozin, saxagliptin or a placebo. See Also: Takeda signs option agreement with Ascentage for CML drug UK’s new Netflix-style funding model for antibiotics goes live The trial’s primary goal was to observe the change in A1C (haemoglobin) levels after 26 weeks compared to placebo for both dapagliflozin and saxagliptin. Secondary objectives included monitoring fasting plasma glucose levels and the percentage of patients achieving an A1C level below 7%. Trial results showed a significant decrease in A1C for patients treated with Farxiga versus those given a placebo. The adjusted mean change in A1C was -0.62% for Farxiga compared to +0.41% for the placebo group. Farxiga demonstrated a clinically meaningful improvement in glycaemic control for children and adolescents with T2D. The asset has also been approved for paediatric patients aged 10 years and above with T2D in 56 countries, based on the T2GO Phase III trial. Further regulatory submissions and market evaluations are underway to determine additional rollout plans. In addition to its use in diabetes management, Forxiga is approved in more than 100 countries for treating heart failure across the full ventricular ejection fraction range and chronic kidney disease in adults. AstraZeneca BioPharmaceuticals Business Unit executive vice-president Ruud Dobber stated: “The prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population. “The approval represents an important milestone for paediatric patients living with type-2 diabetes in the US, extending this medicine’s potential benefits to even more patients facing high unmet needs and reinforcing AstraZeneca’s commitment to delivering innovative treatments across cardiovascular, renal and metabolic diseases.” The latest development comes after AstraZeneca‘s supplemental new drug application for Tagrisso obtained FDA priority review for unresectable Stage III epidermal growth factor receptor-mutated non-small cell lung cancer after chemoradiotherapy.

Phase 3Drug ApprovalClinical ResultPriority Review

12 Jun 2024

·www.biospace.com

FARXIGA approved in the US for the treatment of pediatric type-2 diabetes

US patients aged 10 years and older can now benefit from FARXIGA for type-2 diabetes Approval based on results from T2NOW, one of the largest pediatric type-2 diabetes Phase III trials to date WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca’s FARXIGA® (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older.1 The FDA approval was based on positive results from the pediatric T2NOW Phase III trial.2 FARXIGA was previously approved in the US in adults with T2D as an adjunct to diet and exercise to improve glycemic control.1 Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population. Today’s approval represents an important milestone for pediatric patients living with type-2 diabetes in the US, extending this medicine’s potential benefits to even more patients facing high unmet needs and reinforcing AstraZeneca’s commitment to delivering innovative treatments across cardiovascular, renal and metabolic diseases.” T2D is a chronic disease affecting people of all ages.3,4 The incidence and prevalence of T2D in children and adolescents are increasing globally.5 In the US, there are nearly 30,000 patients under 20 living with T2D with 5,300 new cases diagnosed each year, according to the US Centers for Disease Control and Prevention and recent research.6,7 Younger patients often experience earlier onset of complications and faster advancement of disease compared to adults with the same condition.8-15 Data from the T2NOW Phase III trial, published in The New England Journal of Medicine Evidence, demonstrated a significant reduction in A1C, a marker of average blood sugar, for patients treated with FARXIGA compared to patients receiving placebo.2,16 Adjusted mean change in A1C was -0.62% for FARXIGA versus +0.41% for placebo, a difference of -1.03% (95% CI: -1.57-0.49; p<0.001).2 Statistical significance was achieved in the primary endpoint and in all secondary endpoints versus placebo at week 26, demonstrating FARXIGA can provide clinically meaningful improvements in glycemia for children and adolescents with T2D.2 The safety results in this patient population were consistent with those in adults with T2D, in line with the well-characterised safety pro FARXIGA.2 FARXIGA, a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, was approved in 126 countries, including the EU (marketed under the brand name Forxiga), as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. FARXIGA is also approved for pediatric patients aged 10 years and above with T2D in 56 countries, including the EU and other regions, based on results from the T2GO Phase III clinical trial.17,18 Additional regulatory submissions and rollout plans are under consideration pending further market evaluations. INDICATIONS AND LIMITATIONS OF USE for FARXIGA® (dapagliflozin) FARXIGA is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type-2 diabetes mellitus to reduce the risk of hospitalization for heart failure in adults with type-2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure to reduce the risk of sustained eGFR decline, endstage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression FARXIGA is not recommended for use to improve glycemic control in patients with type-1 diabetes mellitus. FARXIGA is not recommended for use to improve glycemic control in patients with type-2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. FARXIGA is likely to be ineffective in this setting based upon its mechanism of action. FARXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FARXIGA is not expected to be effective in these populations. DOSING To improve glycemic control in adults and pediatric patients aged 10 years and older with T2D, the recommended starting dose is 5 mg orally once daily. Dose can be increased to 10 mg orally once daily for additional glycemic control. For other indications in adults, the recommended dose is 10 mg orally once daily. IMPORTANT SAFETY INFORMATION for FARXIGA® (dapagliflozin) 5 mg and 10 mg Contraindications History of serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA. Warnings and Precautions Ketoacidosis: FARXIGA significantly increases the risk of diabetic ketoacidosis in patients with type-1 diabetes mellitus. Type-2 diabetes mellitus and pancreatic disorders are also risk factors. There have been postmarketing reports of fatal events of ketoacidosis in patients with type-2 diabetes mellitus using SGLT2 inhibitors, including FARXIGA. Consider ketone monitoring in patients with type-1 diabetes mellitus and in others at risk for ketoacidosis. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose levels. If suspected, discontinue FARXIGA, evaluate and treat promptly. Withhold FARXIGA, if possible, in temporary clinical situations that could predispose patients to ketoacidosis. Resume FARXIGA when the patient is clinically stable and has resumed oral intake Volume Depletion: FARXIGA can cause intravascular volume depletion, which may manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type-2 diabetes mellitus receiving SGLT2 inhibitors, including FARXIGA. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating FARXIGA in these patients, assess volume status and renal function. After initiating therapy, monitor for signs and symptoms of hypotension and renal function Urosepsis and Pyelonephritis: SGLT2 inhibitors increase the risk for urinary tract infections (UTIs) and serious UTIs have been reported with FARXIGA. Evaluate for signs and symptoms of UTIs and treat promptly Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Rare but serious, life-threatening cases have been reported in patients with diabetes mellitus receiving SGLT2 inhibitors, including FARXIGA. Cases have been reported in females and males. Serious outcomes have included hospitalization, surgeries, and death. Assess patients presenting with pain or tenderness, erythema, swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue FARXIGA Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections, particularly in patients with prior genital mycotic infections. Monitor and treat appropriately Most Common Adverse Reactions (≥5%): Female genital mycotic infections, nasopharyngitis, and urinary tract infections. Use in Specific Populations Pregnancy: Advise females of potential risk to a fetus especially during the second and third trimesters Lactation: FARXIGA is not recommended when breastfeeding Please see link to US Full Prescribing Information for FARXIGA. Notes T2D T2D is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels, or hyperglycemia.3 Over time, this sustained hyperglycemia contributes to further progression of the disease.3 The prevalence of diabetes is projected to reach 783 million by 2045.3 T2D is the most common type of diabetes, accounting for over 90% of all diabetes worldwide.19 Significant unmet medical need still exists, as many patients have poor blood sugar control and low medication adherence.3,20 T2NOW T2NOW was a randomized, double-blind, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of dapagliflozin as add-on treatment in children and adolescents with T2D receiving metformin, insulin or both.2 Patients were randomized to dapagliflozin, saxagliptin or placebo.2 Those receiving an active drug were further randomized to continue their current dose, or up-titrate to a higher dose of the same active treatment.2 The primary endpoint was change in A1C after 26 weeks vs placebo for dapagliflozin (5 or 10 mg) or saxagliptin (2.5 or 5 mg).2 Secondary endpoints included change in fasting plasma glucose and proportion of patients (A1C ≥7% at baseline) achieving A1C <7.0% (53 mmol/mol) after 26 weeks.2 FARXIGA (dapagliflozin) in the US and marketed as Forxiga in the rest of world, is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. As of June 2024, FARXIGA was approved in 126 countries as an adjunct to diet and exercise to improve glycemic control in adults with T2D. FARXIGA is approved for pediatric patients aged 10 years and above with T2D in the EU and other countries based on the T2GO trial.17,18 In addition, FARXIGA is approved for the treatment of heart failure across the full ventricular ejection fraction range (HFrEF and HFpEF) and CKD in adult patients in more than 100 countries around the world. FARXIGA was the first heart failure medication to demonstrate mortality benefit across the full ejection fraction range.21 Research has shown FARXIGA’s efficacy in preventing and delaying cardiorenal disease, while also protecting the organs – important findings given the underlying links between the heart, kidneys and pancreas.22-24 Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including T2D, heart failure (HF) and chronic kidney disease (CKD).25-28 AstraZeneca in CVRM Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca’s main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys, liver and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection by slowing or stopping disease progression, and ultimately paving the way towards regenerative therapies. The Company’s ambition is to improve and save the lives of millions of people, by better understanding the interconnections between CVRM diseases and targeting the mechanisms that drive them, so we can detect, diagnose and treat people earlier and more effectively. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit and follow us on social media @AstraZeneca. References Farxiga (dapagliflozin) US prescribing information; 2024. Shehadeh N, et al. Dapagliflozin or Saxagliptin in Pediatric Type 2 Diabetes. N Engl J Med Evid. 2023;2(12):1-27. International Diabetes Federation [Internet]. IDF Diabetes Atlas Tenth Edition 2021. Available from: . [Last accessed: 6 June 2024]. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD) [Internet]. Type 2 Diabetes. Available at: . [Last accessed: 6 June 2024]. Wu H, et al. Worldwide estimates of incidence of type 2 diabetes in children and adolescents in 2021. Diabetes Res Clin Pract. 2022;185:109785. Tönnies, T., et al. Projections of Type 1 and Type 2 Diabetes Burden in the U.S. Population Aged <20 Years Through 2060: The SEARCH for Diabetes in Youth Study. Diabetes Care. 2023;46(2):313-320. Centers for Disease Control and Prevention (CDC) [Internet]. Diabetes – National Diabetes Statistics Report. Available at: . [Last accessed: 6 June 2024]. Hillier TA, et al. Complications in young adults with early-onset type 2 diabetes: losing the relative protection of youth. Diabetes Care. 2003;26:2999-3005. Pavkov ME, et al. Effect of youth-onset type 2 diabetes mellitus on incidence of end-stage renal disease and mortality in young and middle-aged Pima Indians. JAMA. 2006;296:421-6. Copeland KC, et al. Characteristics of adolescents and youth with recent-onset type 2 diabetes: the TODAY cohort at baseline. J Clin Endocrinol Metab. 2011;96:159-67. Constantino MI, et al. Long-term complications and mortality in young-onset diabetes: type 2 diabetes is more hazardous and lethal than type 1 diabetes. Diabetes Care. 2013;36:3863-9. Jaiswal M, et al. Prevalence of and Risk Factors for Diabetic Peripheral Neuropathy in Youth With Type 1 and Type 2 Diabetes: SEARCH for Diabetes in Youth Study. Diabetes Care. 2017;40:1226-32. Kim JY, et al. Adipose Tissue Insulin Resistance in Youth on the Spectrum From Normal Weight to Obese and From Normal Glucose Tolerance to Impaired Glucose Tolerance to Type 2 Diabetes. Diabetes Care. 2019;42:265-72. Utzschneider K, et al. Differential loss of β-cell function in youth vs. adults following treatment withdrawal in the Restoring Insulin Secretion (RISE) study. Diabetes Res Clin Pract. 2021;178:108948. Barrett T, et al. Novo Nordisk Pediatric Type 2 Diabetes Global Expert P. Rapid progression of type 2 diabetes and related complications in children and young people-A literature review. Pediatric diabetes. 2020;21:158-72. Centers for Disease Control and Prevention (CDC) [Internet]. Testing for Diabetes and Prediabetes: A1C. Available from: . [Last accessed: 6 June 2024]. European Medicines Agency (EMA) [Internet]. Forxiga 5mg/ 10mg film-coated tablets - Summary of product characteristics. Available at: . [Last accessed: 6 June 2024]. Clinicaltrials.gov [Internet]. Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years. Available at: . [Last accessed: 6 June 2024]. Weng J, et al. Standards of care for type 2 diabetes in China. Diabetes Metab Res Rev. 2016 ;32(5):442-58. Blüher M, et al. Pill Burden in Patients With Type 2 Diabetes in Germany: Subanalysis From the Prospective, Noninterventional PROVIL Study. Clin Diabetes. 2015;33(2):55–61. Jhund P, et al. Dapagliflozin across the range of ejection fraction in patients with heart failure: a patient-level, pooled meta-analysis of DAPA-HF and DELIVER. Nat Med. 2022; 28(9):1956-1964. McMurray JJV, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995-2008. Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436-1446. Wiviott SD, et al. for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes [article and supplementary appendix]. N Engl J Med. 2019;380(4):347-357. Mayo Clinic [Internet]. Heart failure. Available from: . [Last accessed: 6 June 2024]. Vos T, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1211-1259. Centers for Disease Control and Prevention (CDC) [Internet]. A Report Card: Diabetes in the United States. Available from: A Report Card: Diabetes in the United States | Diabetes | CDC. [Last accessed: 6 June 2024]. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [Internet]. Heart disease & kidney disease. Available from: . [Last accessed: 6 June 2024]. View source version on businesswire.com: Contacts Media Inquiries Brendan McEvoy +1 302 885 2677 Chelsea Tressler +1 302 885 2677 US Media Mailbox: usmediateam@astrazeneca.com Source: AstraZeneca View this news release online at:

Phase 3Drug ApprovalClinical Result

14 Feb 2024

·endpts.com

Appeals court sides with AstraZeneca, BMS, McKesson in saxagliptin heart failure case

A Sixth Circuit appeals court this week upheld a decision in favor of AstraZeneca, Bristol Myers Squibb and McKesson in a case alleging that diabetes products containing saxagliptin can cause heart failure. Saxagliptin is the key ingredient in the discontinued type 2 diabetes treatments Onglyza and Kombiglyze. It’s a dipeptidyl peptidase-4 (DPP-4) inhibitor, designed to help lower blood sugar along with diet and exercise. But in 2016, an FDA safety review found that saxagliptin and another DPP-4 inhibitor called alogliptin may increase patients’ risk of heart failure. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Patent Infringement

100 Deals associated with Saxagliptin Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D09753	Saxagliptin Hydrate	A10BH03	DB06335

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	AstraZeneca AB	31 Jul 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Albuminuria	Phase 3	US	AstraZeneca PLC	21 Sep 2015
Albuminuria	Phase 3	JP	AstraZeneca PLC	21 Sep 2015
Albuminuria	Phase 3	AU	AstraZeneca PLC	21 Sep 2015
Albuminuria	Phase 3	CA	AstraZeneca PLC	21 Sep 2015
Albuminuria	Phase 3	MX	AstraZeneca PLC	21 Sep 2015
Albuminuria	Phase 3	ZA	AstraZeneca PLC	21 Sep 2015
Albuminuria	Phase 3	KR	AstraZeneca PLC	21 Sep 2015
Albuminuria	Phase 3	ES	AstraZeneca PLC	21 Sep 2015
Albuminuria	Phase 3	TW	AstraZeneca PLC	21 Sep 2015
Chronic Kidney Diseases	Phase 3	US	AstraZeneca PLC	21 Sep 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04170790 (Pubmed)	Not Applicable	-	18	Saxagliptin 5 mg	ozijhrwxth(idsmgrsknv): T/R = 132.1 (90% CI, 122.7 - 142.3) View more	-	10 Oct 2022
				Sildenafil 50 mg
NCT02917031 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Heart Failure	348	Placebo to match sitagliptin+Saxagliptin (Saxagliptin)	opbqyksgfy(faastupwhd) = yvrdxxkkef wipeejhgpv (phmqkfhwld, zlggiypask - ewmsjydool) View more	-	18 Jun 2021
				Placebo to match saxagliptin (Placebo)	opbqyksgfy(faastupwhd) = ruqigpucki wipeejhgpv (phmqkfhwld, fazcmswyyq - ykdkzrkhhk) View more
NCT02597101 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Insulin Resistance \| Obesity	14	placebo+metformin+saxagliptin (Placebo)	qnlzkhgonc(tyhihruoqf) = rugzodkegw yjnhoplwpu (ipbvexwrvt, nizkoyxdue - ulphsrvhxz) View more	-	13 May 2021
				AZD9668+metformin+saxagliptin (AZD9668)	qnlzkhgonc(tyhihruoqf) = kmqsrovllq yjnhoplwpu (ipbvexwrvt, gxatztiwgb - vkrzpegjnc) View more
NCT02419612 (Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	444	dapagliflozin + saxagliptin	lxjzvibabn(qnmnetaxbr) = htmklsjovu wkfytmvmfu (etmtiacskz ) View more	Superior	01 Jul 2020
				glimepiride	lxjzvibabn(qnmnetaxbr) = cokufdafxg wkfytmvmfu (etmtiacskz ) View more
NCT01548651 (CTgov)	Phase 4	Glucose Intolerance \| Inflammation	8	Placebo (Placebo)	vjvirigcxg(udjliggnyi) = fhofaymafq fncwfaqjnw (nkryfmubgp, fgwrirdhqb - ptyzsimqcb) View more	-	13 Jan 2020
				Saxagliptin (Saxagliptin)	vjvirigcxg(udjliggnyi) = ehgtygcytl fncwfaqjnw (nkryfmubgp, rwbyfvbaqz - kcaccczlif) View more
Pubmed \| Diabetes Obes Metab	Not Applicable	Diabetes Mellitus, Type 2	-	Dapagliflozin 10 mg/day	sgwplillcl(hfedvrwoog): CoF = -1.38 (95% CI, -2.41 to -0.35)	-	01 Nov 2019
				Saxagliptin 5 mg/day
NCT02613897 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	56	Saxagliptin+Dapagliflozin (DAPA/SAXA (Dapagliflozin Plus Saxagliptin))	rvxkrtwyyo(dhvulewjqd) = qogoggiasw mymwfuhngf (vmglgiogbq, duelbajcka - ofawxnyyds) View more	-	14 Aug 2019
				Dapagliflozin (DAPA (Dapagliflozin Plus Placebo))	rvxkrtwyyo(dhvulewjqd) = zrcfasaanf mymwfuhngf (vmglgiogbq, ynrioqyojh - sahtrvzcuh) View more
NCT02547935 (CTgov)	Phase 2/3	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases \| Albuminuria	459	Matching Placebo for Dapagliflozin 10 mg	sfiazvocrl(aprqvyfjne) = ndraiubvnm onpvylqrec (kkmxekpebk, zmfepqwonz - frpzllhmyl) View more	-	04 Jun 2019
NCT02280486 (SPECIFY, Pubmed \| Diabetes Obes Metab)	Phase 4	-	388	Saxagliptin	ujkbrzodqi(cwpjqwwuxn) = suybstjljb zqaexaaemd (jnirihlhqh ) View more	Positive	01 Apr 2019
				Glimepiride	ugprzyrbvz(onmhvimwev) = rwbcmfnijs fqivlfysne (sxslsfsvdj )
NCT02471404 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	939	Dapaglifozin (Dapaglifozin 10mg)	pftekexlcy(owcmkcgwot) = ucoonevmva jzngedpzlo (ttifmhxmkf, zueyillbqe - skszlkbnxl) View more	-	26 Mar 2019
				Saxagliptin+Dapagliflozin (Saxagliptin 5mg and Dapagliflozin 10mg)	pftekexlcy(owcmkcgwot) = evxmsyrhlz jzngedpzlo (ttifmhxmkf, hoioelvtnb - pvhdfrtkqo) View more

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