Role of sodium glucose cotransporter-2 inhibitors in type I diabetes mellitus

Diabetes, Metabolic Syndrome and Obesity

Volumn 10, Issue , 2017, Pages 161-167

  Ahmadieh, Hala ^a   Ghazal, Nisrine ^b   Azar, Sami T ^b  

^a BEIRUT ARAB UNIVERSITY   (Lebanon)

^b AMERICAN UNIVERSITY OF BEIRUT   (Lebanon)

Author keywords

Euglucemic diabetic ketoacidosis; Glycemic control; Glycosylated hemoglobin; Oral antidiabetics

Indexed keywords

CANAGLIFLOZIN; DAPAGLIFLOZIN; EMPAGLIFLOZIN; HEMOGLOBIN A1C; PLACEBO; REMOGLIFLOZIN ETABONATE; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; SOTAGLIFLOZIN;

DIABETIC KETOACIDOSIS; DRUG EFFICACY; DRUG SAFETY; DRUG USE; GLUCOSE HOMEOSTASIS; GLYCEMIC CONTROL; HEART PROTECTION; HUMAN; INCIDENCE; INSULIN DEPENDENT DIABETES MELLITUS; METABOLIC REGULATION; NONHUMAN; OXIDATIVE STRESS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RENAL PROTECTION; REVIEW;

EID: 85020511602     PISSN: None     EISSN: 11787007     Source Type: Journal    
DOI: 10.2147/DMSO.S122767     Document Type: Review

References (64)

1. American Diabetes Association. Standards of medical care in diabetes-2013. Diabetes Care. 2013;35:S11–S63.
2. Gorsuch A, Spencer K, Lister J, et al. Evidence for a long prediabetic period in type 1 (insulin-dependent) diabetes mellitus. Lancet. 1981; 2(8260–8261):1363–1365.
3. Knip M, Siljander H. Autoimmune mechanisms in type 1 diabetes. Autoimmunity Rev. 2008;7(7):550–557.
4. Kilpatrick ES, Rigby AS, Atkin SL. Insulin resistance, the metabolic syndrome, and complication risk in type 1 diabetes: “double diabetes” in the Diabetes Control and Complications Trial. Diabetes Care. 2007;30: 707–771.
5. George P, McCrimmon RJ. Potential role of non-insulin adjunct therapy in type 1 diabetes. Diabetic Med. 2013;30:179–188.
6. Vella S, Buetow L, Royle P, Livingstone S, Colhoun HM, Petrie JR. The use of metformin in type 1 diabetes: a systematic review of efficacy. Diabetologia. 2010;53(5):809–820.
7. Bhat R, Bhansali A, Bhadada S, Sialy R. Effect of pioglitazone therapy in lean type 1 diabetes mellitus. Diabetes Res Clin Pract. 2007;78:349–354.
8. Stone M, Walker J, Chisholm D, et al. The addition of rosiglitazone to insulin in adolescents with type 1 diabetes and poor glycaemic control: a randomized-controlled trial. Pediatr Diabetes. 2008;9(4 Pt 1):326–334.
9. Rabasa-Lhoret R, Burelle Y, Ducros F, et al. Use of an alpha-glucosidase inhibitor to maintain glucose homoeostasis during postprandial exercise in intensively treated type 1 diabetic subjects. Diabet Med. 2001;18(9):739–744.
10. Nagai E, Katsuno T, Miyagawa J, et al. Effects of miglitol in combination with intensive insulin therapy on blood glucose control with special reference to incretin responses in type 1 diabetes mellitus. Endocr J. 2011;58:869–877.
11. Whitehouse F, Kruger D, Fineman M, et al. A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes. Diabetes Care. 2002; 25:724–730.
12. Ratner R, Whitehouse F, Fineman MS, et al. Adjunctive therapy with pramlintide lowers HbA1C without concomitant weight gain and increased risk of severe hypoglycemia in patients with type 1 diabetes approaching glycemic targets. Exp Clin Endocrinol Diabetes. 2005;113:199–204.
13. Garg SK, Moser EG, Bode BW, et al. Effect of sitagliptin on postprandial glucagon and GLP-1 levels in patients with type 1 diabetes: Investigator-initiated, double-blind, randomized, placebo-controlled trial. Endocr Pract. 2013;19:19–28.
14. Kielgast U, Krarup T, Holst JJ, Madsbad S. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function. Diabetes Care. 2011;34:1463–1468.
15. Polsky S, Ellis SL. Obesity, insulin resistance, and type 1 diabetes mellitus. Curr Opin Endocrinol Diabetes Obes. 2015;22(4):277–282.
16. Vick H, Diedrich DF, Baumann K. Reevaluation of renal tubular glucose transport inhibition by phlorizin analogs. Am J Physiol. 1973;224(3):552–557.
17. Vallon V, Thomson SC. Renal function in diabetic disease models: the tubular system in the pathophysiology of the diabetic kidney. Annu Rev Physiol. 2012;74:351–375.
18. Washburn WN, Poucher SM. Differentiating sodium-glucose cotransporter-2 inhibitors in development for the treatment of type 2 diabetes mellitus. Expert Opin Investig Drugs. 2013;22:463–486.
19. FORXIGA™ (dapagliflozin) now approved in European Union for treatment of type 2 diabetes. November 2012. Available from: https:// www.astrazeneca.com/media-centre/press-releases/2012/FORXIGAdapagliflozin-now-approved-in-European-Union-for-treatment-of-type-2-diabetes-14112012. Accessed November 14, 2012.
20. FDA approves Invokana to treat type 2 diabetes. March 2013. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm345848.htm. Accessed November 14, 2012.
21. FDA approves Jardiance (empagliflozin) to treat type 2 diabetes. August 2014. Available from: https://www.drugs.com/newdrugs/fdaapproves-jardiance-empagliflozin-type-2-diabetes-4064.html. Accessed November 14, 2012.
22. Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010;33(10):2217–2224.
23. Bailey CJ, Iqbal N, T’Joen C, List JF. Dapagliflozin monotherapy in drug-naive patients with diabetes: a randomized-controlled trial of low-dose range. Diabetes Obes Metab. 2012;14(10):951–959.
24. Kaku K, Kiyosue A, Inoue S, et al. Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Diabetes Obes Metab. 2014;16(11):1102–1110.
25. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo controlled trial. Lancet. 2010;375(9733):2223–2233.
26. Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012;66(5):446–456.
27. Rosenstock J, Seman LJ, Jelaska A, et al. Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia. Diabetes Obes Metab. 2013;15(12):1154–1160.
28. Haring HU, Merker L, Seewaldt-Becker E, et al. Empagliflozin as add-on to metformin in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2014;37(6):1650–1659.
29. Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011;13(10):928–938.
30. Haring HU, Merker L, Seewaldt-Becker E, et al. Empagliflozin as addon to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2014;37:1480–1483.
31. Wilding J, Charpentier G, Hollander P, et al. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial. Int J Clin Pract. 2013;67(12):1267–1282.
32. Forst T, Guthrie R, Goldenberg R, et al. Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes on background metformin and pioglitazone. Diabetes Obes Metab. 2014;16(5):467–477.
33. Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012;35(7):1473–1478.
34. Kovacs C, Seshiah V, Swallow R, et al. Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24-week, randomized, placebo-controlled trial. Diabetes Obes Metab. 2014;16(2):147–158.
35. Jabbour SA, Hardy E, Sugg J, et al. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740–750.
36. Roden M, Weng J, Eilbracht J, et al. Empagliflozin monotherapy in drug-naıve patients with type 2 diabetes: a randomised, 24-week, double-blind, placebo-controlled, parallel group, trial with sitagliptin as active comparator. Lancet Diabetes Endocrinol. 2013;1(3):208–219.
37. 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.
38. Liakos A, Karagiannis T, Athanasiadou E, et al. Efficacy and safety of empagliflozin for type 2 diabetes: a systematic review and meta-analysis. Diabetes Obes Metab. 2014;16(10):984–993.
39. Yang X, Lai D, Zhong X, Shen HP, Huang YL. Efficacy and safety of canagliflozin in subjects with type 2 diabetes: systematic review and meta-analysis. Eur J Clin Pharmacol. 2014;70(10):1149–1158.
40. Scheen A. Pharmacodynamics, efficacy and safety of sodium–glucose co-transporter type 2 (SGLT2) inhibitors for the treatment of type 2 diabetes mellitus. Drugs. 2015;75:33–59.
41. Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013;15(9):853–862.
42. Majewski C, Bakris G. Blood pressure reduction: an added benefit of sodium–glucose cotransporter 2 inhibitors in patients with type 2 diabetes. Diabetes Care. 2015;48:429–430.
43. Reddy R, Inzucchi S. SGLT2 inhibitors in the management of type 2 diabetes. Endocrine. 2016;53(2):364–372.
44. Luippold G, Klein T, Mark M, Grempler R. Empagliflozin, a novel potent and selective SGLT-2 inhibitor, improves glycaemic control alone and in combination with insulin in streptozotocin-induced diabetic rats, a model of type 1 diabetes mellitus. Diabetes Obes Metab. 2012;14:601.
45. Cheng S, Chen L, Li S, Mayoux E, Leung PS. The effects of empagliflozin, an SGLT2 inhibitor, on pancreatic β-cell mass and glucose homeostasis in type 1 diabetes. PLoS One. 2016;11(1):e0147391.
46. Perkins B, Cherney D, Partridge H, et al. Sodium-glucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-of-concept trial. Diabetes Care. 2014;37: 1480–1483.
47. Mudaliar S, Armstrong D, Mavian A, et al. Remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2, improves serum glucose profiles in type 1 diabetes. Diabetes Care. 2012;35:2198–2200.
48. Henry R, Rosenstock J, Edelman S, et al. Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study. Diabetes Care. 2015;38(3):412–419.
49. Henry R, Thakkar P, Tong C, Polidori D, Alba M. Efficacy and safety of canagliflozin, a sodium glucose cotransporter 2 inhibitor, as add-on to insulin in patients with type 1 diabetes. Diabetes Care. 2015;38(12):2258–2265.
50. Sands A, Zambrowicz B, Rosenstock J, et al. Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes. Diabetes Care. 2015;38(7):1181–11188.
51. Cherney DZ, Perkins BA, Soleymanlou N, et al. Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus. Circulation. 2014;129(5):587–597.
52. Cnop M, Welsh N, Jonas J-C, Jörns A, Lenzen S, Eizirik DL. Mechanisms of pancreatic-cell death in type 1 and type 2 diabetes many differences, few similarities. Diabetes. 2005;54(2):S97–S107.
53. Vetere A, Choudhary A, Burns SM, Wagner BK. Targeting the pancreatic β-cell to treat diabetes. Nat Rev Drug Discov. 2014;13: 278–289.
54. Jurczak MJ, Lee HY, Birkenfeld AL, et al. SGLT2 deletion improves glucose homeostasis and preserves pancreatic B-cell function. Diabetes. 2011;60(3):890–898.
55. Cheng ST, Chen L, Li SYT, Mayoux E, Leung PS. The effects of empagliflozin, an SGLT2 inhibitor, on pancreatic β-cell mass and glucose homeostasis in type 1 diabetes. PLoS One. 2016;11(1):e0147391.
56. Stenlof K, Cefalu WT, Kim KA, et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013; 15(4):372–382.
57. Kalra S, Sahay R, Gupta Y. Sodium glucose transporter 2 (SGLT2) inhibition and ketogenesis. Indian J Endocrinol Metab. 2015;19(4):524.
58. Kalra S, Gupta Y, Patil S. Sodium-glucose cotransporter-2 inhibition and the insulin: glucagon ratio: unexplored dimensions. Indian J Endocrinol Metab. 2015;19:426–429.
59. U.S. Food and Drug Administration. Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood [Internet], 15 May 2015. Available from: http://www.fda.gov/ downloads/Drugs/DrugSafety/UCM446954.pdf. Accessed June 22, 2015.
60. European Medicines Agency. Review of diabetes medicines called SGLT2 inhibitors started: risk of diabetic ketoacidosis to be examined [Internet], 12 June 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/SGLT2_inhibitors__20/Procedure_started/WC500187926.pdf. Accessed June 22, 2015.
61. Abdul-Ghani M, Del Prato S, Chilton R, DeFronzo RA. SGLT2 inhibitors and cardiovascular risk: lessons learned from the EMPA-REG OUTCOME study. Diabetes Care. 2016;39(5):717–725.
62. Mudaliar S, Alloju S, Henry RR. Can a shift in fuel energetics explain the beneficial cardiorenal outcomes in the EMPA-REG OUTCOME study? A unifying hypothesis. Diabetes Care. 2016;39(7):1115–1122.
63. Tomaselli GF, Zipes DP. What causes sudden death in heart failure? Circ Res. 2004;95:754–763.
64. Cahill GF Jr, Veech RL. Ketoacids? Good medicine? Trans Am Clin Climatol Assoc. 2003;114:149–161.