Ertugliflozin as a monotherapy for the treatment of type 2 diabetes

References

• Cefalu WT, Buse JB, Tuomilehto J, et al. Update and next steps for real-world translation of interventions for type 2 diabetes prevention: reflections from a diabetescare editors’ expert forum. Diabetes Care. 2016;39(7):1186–1201.
   PubMed Web of Science ®Google Scholar
• Tan X, Hu J. Combination therapy for type 2 diabetes: dapagliflozin plus metformin. Expert Opin Pharmacother. 2016;17(1):117–126.
   PubMed Web of Science ®Google Scholar
• Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364–1379.
   PubMed Web of Science ®Google Scholar
• Esposito K, Chiodini P, Bellastella G, et al. Proportion of patients at HbA1c target <7% with eight classes of antidiabetic drugs in type 2 diabetes: systematic review of 218 randomized controlled trials with 78 945 patients. Diabetes Obes Metab. 2012;14:228–233.
   PubMed Web of Science ®Google Scholar
• Corathers SD, Peavie S, Salehi M. Complications of diabetes therapy. Endocrinol Metab Clin North Am. 2013;42(4):947–970.
   PubMed Web of Science ®Google Scholar
• Abdul-Ghani MA, DeFronzo RA. Inhibition of renal glucose reabsorption: a novel strategy for achieving glucose control in type 2 diabetes mellitus. Endocr Pract. 2008;14:782–790.
   PubMedGoogle Scholar
• Katsiki N, Papanas N, Mikhailidis DP. Dapagliflozin: more than just another oral glucose-lowering agent? Expert Opin Investig Drugs. 2010;19:1581–1589.
   PubMed Web of Science ®Google Scholar
• Pfizer. FDA approves SGLT2 inhibitor SteglatroTM (ertugliflozin) and fixed-dose combination SteglujanTM (ertugliflozin and sitagliptin) for adults with type 2 diabetes. 2017 [cited 2018 May 20]. Available from: http://www.pfizer.com/
   Google Scholar
• Merck & Co Inc. STEGLATROTM (ertugliflozin) tablets, for oral use: prescribing information. 2017 [cited 2018 May 20]. Available from: http://www.merck.com/
   Google Scholar
• Mascitti V, Maurer TS, Robinson RP, et al. Discovery of a clinical candidate from the structurally unique dioxa-bicyclo[3.2.1]octane class of sodium-dependent glucose cotransporter 2inhibitors. J Med Chem. 2011;54(8):2952–2960.
   PubMed Web of Science ®Google Scholar
• Kalgutkar AS, Tugnait M, Zhu T, et al. Preclinical species and human disposition of PF-04971729, a selective inhibitor of the sodium- dependent glucose cotransporter 2 and clinical candidate for the treatment of type 2 diabetes mellitus. Drug Metab Dispos. 2011;39(9):1609–1619.
   PubMed Web of Science ®Google Scholar
• Miao Z, Nucci G, Amin N, et al. Pharmacokinetics, metabolism, and excretion of the antidiabetic agent ertugliozin (PF-04971729) in healthy male subjects. Drug Metab Dispos. 2013;41(2):445–456.
   PubMed Web of Science ®Google Scholar
• Dash RP, Babu RJ, Srinivas NR. Comparative pharmacokinetics of three SGLT-2 inhibitors sergliozin, remogliozin and ertugliozin: an overview. Xenobiotica. 2017;47(11):1015–1026.
   Google Scholar
• Kumar V, Sahasrabudhe V, Matschke K, et al. Lack of a pharmacokinetic interaction between ertugliozin and sitagliptin or metformin in healthy subjects. Poster presented at: ASCPT 2016 Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; 2016 Mar 12; San Diego, CA.
   Google Scholar
• Sahasrabudhe V, Terra SG, Hickman A, et al. The effect of renal impairment on the pharmacokinetics and pharmacodynamics of ertugliflozin in subjects with type 2 diabetes mellitus. J Clin Pharmacol. 2017;57(11):1432–1443.
   PubMed Web of Science ®Google Scholar
• Terra SG, Focht K, Davies M, et al. Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone. Diabetes Obes Metab. 2017;19(5):721–728.
   PubMed Web of Science ®Google Scholar
• Amin NB, Wang X, Mitchell JR, et al. Blood pressure-lowering effect of the sodium glucose co-transporter-2 inhibitor ertugliflozin, assessed via ambulatory blood pressure monitoring in patients with type 2 diabetes and hypertension. Diabetes Obes Metab. 2015;17(8):805–808.
   PubMed Web of Science ®Google Scholar
• Aronson R, Frias J, Goldman A, et al. Long-term efficacy and safety of ertugliflozin monotherapy in patients with inadequately controlled T2DM despite diet and exercise: VERTIS MONO extension study. Diabetes Obes Metab. 2018;20(6):1453–1460.
   PubMed Web of Science ®Google Scholar
• Hollander P, Liu J, Hill J, et al. Ertugliflozin compared with glimepiride in patients with Type 2 diabetes mellitus inadequately controlled on metformin: the VERTIS SU randomized study. Diabetes Ther. 2018;9(1):193–207.
   PubMed Web of Science ®Google Scholar
• Grunberger G, Camp S, Johnson J, et al. Ertugliflozin in patients with stage 3 chronic kidney disease and type 2 diabetes mellitus: the VERTIS RENAL randomized study. Diabetes Ther. 2018;9(1):49–66.
   PubMed Web of Science ®Google Scholar
• Trujillo JM, Nuffer WA. Impact of sodium-glucose cotransporter 2 inhibitors on nonglycemic outcomes in patients with type 2 diabetes. Pharmacotherapy. 2017;37(4):481–491.
   PubMed Web of Science ®Google Scholar
• Scheen AJ. Pharmacodynamics, efficacy and safety of sodium-glucose co-transporter type 2 (SGLT2) inhibitors for the treatment of type 2 diabetes mellitus. Drugs. 2015;75(1):33–59.
   PubMed Web of Science ®Google Scholar
• Filippas-Ntekouan S, Filippatos TD, Elisaf MS. SGLT2 inhibitors: are they safe? Postgrad Med. 2018;130(1):72–82.
   PubMed Web of Science ®Google Scholar
• Zinman B, Wanner C, Lachin JM, et al. EMPA-REG OUTCOME investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117–2128.
   PubMed Web of Science ®Google Scholar
• Neal B, Perkovic V, Mahaffey KW, et al. CANVAS program collaborative group. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377:644–657.
   PubMed Web of Science ®Google Scholar
• Sahasrabudhe V, Saur D, Matschke K, et al. A phase 1, randomized, placebo-and active-controlled crossover study to determine the effect of single-dose ertugliflozin on QTc interval in healthy volunteers. Clin Pharmacol Drug Dev. 2018;7(5):513–523.
   PubMed Web of Science ®Google Scholar
• Tropeano AI. Mechanism of diabetic complications: “therapeutic” perspectives. Ann Endocrinol. 2003;64:474–476.
   PubMedGoogle Scholar
• Merck & Co Inc. SEGLUROMETTM (ertugliflozin and metformin hydrochloride) tablets, for oral use: prescribing information. 2017 [cited 2018 May 20]. Available from: http://www.accessdata.fda.gov/
   Google Scholar
• Merck & Co Inc. STEGLUJANTM (ertugliflozin and sitagliptin) tablets, for oral use: prescribing information. 2017 [cited 2018 May 20]. Available from: http://www.accessdata.fda.gov/
   Google Scholar
• NCT01986881. Cardiovascular outcomes following ertugliflozin treatment in type 2 diabetes mellitus participants with vascular disease, The VERTIS CV study (MK-8835-004). [cited 2018 May 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT01986881
   Google Scholar