Sodium-glucose co-transporter-2 inhibitors as add-on therapy to insulin: rationale and evidences

References

• DeFronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58:773–795.
   PubMed Web of Science ®Google Scholar
• Turnbull FM, Abraira C, Anderson RJ, et al. Control Group. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia. 2009;52:2288–2298.
   PubMed Web of Science ®Google Scholar
• Hoerger TJ, Segel JE, Gregg EW, et al. Is glycemic control improving in U.S. adults? Diabetes Care. 2008;31:81–86.
   PubMed Web of Science ®Google Scholar
• Buse J. Combining insulin and oral agents. Am J Med. 2000;108(Suppl 6a):23S–32S.
   PubMedGoogle Scholar
• Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011;154(2):103–112.
   PubMed Web of Science ®Google Scholar
• Seino Y, Min KW, Takami A, et al. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012;14(10):910–917.
   PubMed Web of Science ®Google Scholar
• Riddle MC, Forst T, Aronson R, et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care. 2013;36(9):2497–2503.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Fonseca VA, Gross JL, et al. Harmony 6 Study Group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014;37(8):2317–2325.
   PubMed Web of Science ®Google Scholar
• Morales J, Merker L. Minimizing hypoglycemia and weight gain with intensive glucose control: potential benefits of a new combination therapy (IDegLira). Adv Ther. 2015;32(5):391–403.
   PubMed Web of Science ®Google Scholar
• Vilsbøll T, Rosenstock J, Yki-Järvinen H, et al. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12:167–177.
   PubMed Web of Science ®Google Scholar
• Hong ES, Khang AR, Yoon JW, et al. Comparison between sitagliptin as add-on therapy to insulin and insulin dose increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes Obes Metab. 2012;14:795–802.
   PubMed Web of Science ®Google Scholar
• Barnett AH, Charbonnel B, Donovan M, et al. Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin. Curr Med Res Opin. 2012;28:513–523.
   PubMed Web of Science ®Google Scholar
• Kothny W, Foley J, Kozlovski P, et al. Improved glycaemic control with vildagliptin added to insulin, with or without metformin, in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2013;15:252–257.
   PubMed Web of Science ®Google Scholar
• Barnett AH, Charbonnel B, Li J, et al. Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy. Clin Drug Investig. 2013;33:707–717.
   PubMed Web of Science ®Google Scholar
• Yki-Järvinen H, Rosenstock J, Durán-Garcia S, et al. Effects of adding linagliptin to basal insulin regimen for inadequately controlled type 2 diabetes: a ≥ 52-week randomized, double-blind study. Diabetes Care. 2013;36:3875–3881.
   PubMed Web of Science ®Google Scholar
• Otsuka Y, Yamaguchi S, Furukawa A, et al. Addition of sitagliptin or metformin to insulin monotherapy improves blood glucose control via different effects on insulin and glucagon secretion in hyperglycemic Japanese patients with type 2 diabetes. Endocr J. 2015;62:133–143.
   PubMed Web of Science ®Google Scholar
• Sato S, Saisho Y, Kou K, et al. Efficacy and safety of sitagliptin added to insulin in Japanese patients with type 2 diabetes: the EDIT randomized trial. PLoS One. 2015;10(3):e0121988.
   Web of Science ®Google Scholar
• Mathieu C, Shankar RR, Lorber D, et al. A randomized clinical trial to evaluate the efficacy and safety of co-administration of sitagliptin with intensively titrated insulin glargine. Diabetes Ther. 2015;6(2):127–142.
   PubMed Web of Science ®Google Scholar
• Vasilakou D, Karagiannis T, Athanasiadou E, et al. Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013;159:262–274.
   PubMed Web of Science ®Google Scholar
• Mudaliar S, Henry RR, Boden G, et al. Changes in insulin sensitivity and insulin secretion with the sodium glucose cotransporter 2 inhibitor dapagliflozin. Diabetes Technol Ther. 2014;16(3):137–144.
   PubMed Web of Science ®Google Scholar
• Merovci A, Solis-Herrera C, Daniele G, et al. Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. J Clin Invest. 2014;124:509–514.
   PubMed Web of Science ®Google Scholar
• Ferrannini E, Muscelli E, Frascerra S, et al. Metabolic response to sodium-glucose co-transporter 2 inhibition in type 2 diabetic patients. J Clin Invest. 2014;124:499–508.
   PubMed Web of Science ®Google Scholar
• Inzucchi SE, Zinman B, Wanner C, et al. SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials. Diab Vasc Dis Res. 2015;12(2):90–100.
   PubMed Web of Science ®Google Scholar
• Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. NEJM. 2015;373:2117–2128. DOI:10.1056/NEJMoa1504720. [Epub ahead of print].
   PubMed Web of Science ®Google Scholar
• Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions version 5.1.0 [Internet]. The Cochrane Collaboration; 2011 [updated 2011 Mar; cited 2015 Oct 1]. Available from: http://www.cochrane-handbook.org
   Google Scholar
• Wilding JP, Norwood P, T’joen C, et al. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment. Diabetes Care. 2009;32:1656–1662.
   PubMed Web of Science ®Google Scholar
• Wilding JP, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin. Ann Intern Med. 2012;156:405–415.
   PubMed Web of Science ®Google Scholar
• Devineni D, Morrow L, Hompesch M, et al. Canagliflozin improves glycaemic control over 28 days in subjects with type 2 diabetes not optimally controlled on insulin. Diab Obes Metab. 2012;14(6):539–545.
   PubMed Web of Science ®Google Scholar
• Dumas R, Davies M, Rosenstock J, et al. Effects of canagliflozin added on to basal insulin ± other antihyperglycemic agents in type 2 diabetes. Can J Diabetes. 2013;37:S13–S84. Abstract 73.
   Google Scholar
• Wilding JP, Woo V, Rohwedder K, et al. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab. 2014;16(2):124–136.
   PubMed Web of Science ®Google Scholar
• van Haalen HG, Pompen M, Bergenheim K, et al. Cost effectiveness of adding dapagliflozin to insulin for the treatment of type 2 diabetes mellitus in the Netherlands. Clin Drug Investig. 2014;34(2):135–146.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Jelaska A, Frappin G, et al. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014;37(7):1815–1823.
   PubMed Web of Science ®Google Scholar
• Neal B, Perkovic V, de Zeeuw D, et al. Efficacy and safety of canagliflozin, an inhibitor of sodium–glucose cotransporter 2, when used in conjunction with insulin therapy in patients with type 2 diabetes. Diabetes Care. 2015;38(3):403–411.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Jelaska A, Zeller C, et al. Impact of empagliflozin added on to basal insulin in type 2 diabetes inadequately controlled on basal insulin: a 78-week randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2015;17(10):936–948.
   PubMed Web of Science ®Google Scholar
• Koro CE, Bowlin SJ, Bourgeois N, et al. Glycemic control from 1988 to 2000 among U.S. adults diagnosed with type2 diabetes: a preliminary report. Diabetes Care. 2004;27:17–20.
   PubMed Web of Science ®Google Scholar
• Yki-Jarvinen H. Combination therapies with insulin in type 2 diabetes. Diabetes Care. 2001;24:758–767.
   PubMed Web of Science ®Google Scholar
• Carver C. Insulin treatment and the problem of weight gain in type 2 diabetes. Diabetes Educ. 2006;32:910–917.
   PubMed Web of Science ®Google Scholar
• Russell-Jones D, Khan R. Insulin-associated weight gain in diabetes–causes,effects and coping strategies. Diabetes Obes Metab. 2007;9:799–812.
   PubMed Web of Science ®Google Scholar
• UK Prospective Diabetes Study (UKPDS) 34 Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352(9131):854–865.
   PubMed Web of Science ®Google Scholar
• McAdam-Marx C, Mukherjee J, Bellows BK, et al. Evaluation of the relationship between weight change and glycemic control after initiation of antidiabetic therapy in patients with type 2 diabetes using electronic medical record data. Diabetes Res Cin Pract. 2014;103(3):402–411.
   PubMed Web of Science ®Google Scholar