Combination therapy for type 2 diabetes: Dapagliflozin plus metformin

Expert Opinion on Pharmacotherapy

Volumn 17, Issue 1, 2016, Pages 117-126

  Tan, Xueying ^a   Hu, Jingbo ^b  

^a Yuyao People's Hospital   (China)

^b ZHEJIANG UNIVERSITY   (China)

Author keywords

combination therapy; dapagliflozin; metformin; sodium glucose co transporter 2 (SGLT2) inhibitor; type 2 diabetes

Indexed keywords

BIGUANIDE; DAPAGLIFLOZIN; DAPAGLIFLOZIN PLUS METFORMIN; METFORMIN; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; 2-(3-(4-ETHOXYBENZYL)-4-CHLOROPHENYL)-6-HYDROXYMETHYLTETRAHYDRO-2H-PYRAN-3,4,5-TRIOL; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; GLUCOSE BLOOD LEVEL; GLUCOSIDE; SLC5A2 PROTEIN, HUMAN; SODIUM GLUCOSE COTRANSPORTER 2;

ARTICLE; BLOOD PRESSURE; BODY WEIGHT; CLINICAL TRIAL (TOPIC); DRUG EFFICACY; DRUG MECHANISM; DRUG METABOLISM; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; GLYCEMIC CONTROL; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); WEIGHT REDUCTION; ANTAGONISTS AND INHIBITORS; COMBINATION DRUG THERAPY; DIABETES MELLITUS, TYPE 2; GLUCOSE BLOOD LEVEL; METABOLISM;

BENZHYDRYL COMPOUNDS; BLOOD GLUCOSE; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; GLUCOSIDES; HUMANS; HYPOGLYCEMIC AGENTS; METFORMIN; SODIUM-GLUCOSE TRANSPORTER 2;

EID: 84955642057     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2016.1121235     Document Type: Article

References (57)

1. American Diabetes Association. Standards of medical care in diabetes-2015. Diabetes Care. 2015;38(Suppl. 1):S1-S49.
2. 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.
3. Emerging Risk Factors Collaboration. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: A collaborative meta-analysis of 102 prospective studies. Lancet. 2010;375:2215-2222.
4. Khaw K-T, Wareham N, Luben R, et al. Glycated haemoglobin, diabetes, and mortality in men in Norfolk cohort of European Prospective Investigation of Cancer and Nutrition (EPIC-Norfolk). BMJ. 2001;322:15-18.
5. Reichard P, Nilsson BY, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med. 1993;329:304-309.
6. Ray KK, Seshasai SR, Wijesuriya S, et al. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: A metaanalysis of randomised controlled trials. Lancet. 2009;373:1765-1772.
7. Ismail-Beigi F. Glycemic management of type 2 diabetes mellitus. N Engl J Med. 2012;366:1319-1327.
8. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: A patient-centered approach: Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38:140-149.
9. Hundal RS, Krssak M, Dufour S, et al. Mechanism by which metformin reduces glucose production in type 2 diabetes. Diabetes. 2000;49:2063-2069.
10. Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996;334:574-579.
11. Katsiki N, Papanas N, Mikhailidis DP. Dapagliflozin: More than just another oral glucose-lowering agent? Expert Opin Investig Drugs. 2010;19:1581-1589.
12. Bailey CJ, Gross JL, Pieters A, et al. 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;375:2223-2233.
13. Nauck MA, Del PS, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: A randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011;34:2015-2022.
14. Bailey CJ, Gross JL, Hennicken D, et al. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: A randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013;11:43.
15. Bolinder J, Ljunggren O, Kullberg J, et al. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012;97:1020-1031.
16. Bailey CJ, Day C. Fixed-dose single tablet antidiabetic combinations. Diabetes Obes Metab. 2009;11:527-533.
17. Hutchins V, Zhang B, Fleurence RL, et al. A systematic review of adherence, treatment satisfaction and costs, in fixed-dose combination regimens in type 2 diabetes. Curr Med Res Opin. 2011;27:1157-1168.
18. Hanefeld M, Bornstein SR, Barthel A. Modern medical treatment of type 2 diabetes. Dtsch Med Wochenschr. 2014;139:2494-2497.
19. Vallon V, Platt KA, Cunard R, et al. SGLT2 mediates glucose reabsorption in the early proximal tubule. J Am Soc Nephrol. 2011;22:104-112.
20. 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.
21. Wright EM. Renal Na(+)-glucose cotransporters. Am J Physiol Renal Physiol. 2001;280:10-18.
22. Gerich JE. Role of the kidney in normal glucose homeostasis and in the hyperglycaemia of diabetes mellitus: Therapeutic implications. Diabet Med. 2010;27:136-142.
23. List JF, Whaley JM. Glucose dynamics and mechanistic implications of SGLT2 inhibitors in animals and humans. Kidney Int Suppl. 2011;120:S20-S27.
24. European Commission, Public Health. Community register of medicinal products for human use. Invokana [Internet]. 2013 [cited 2013 Dec 3]. Available from: Http://ec.europa.eu/health/documents/com munity-register/html/h884. htm#EndOfPage
25. US Food and Drug Administration. FDA news release: FDA approves Farxiga to treat type 2 diabetes [Internet]. 2014 [cited 2014 Sept 2]. Available from: Http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm380829.htm
26. Farxiga® (dapagliflozin). Full prescribing information. Princeton (NJ): Bristol-Myers Squibb; 2014.
27. Rosenstock J, Vico M, Wei L, et al. Effects of dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, on hemoglobin A1c, body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012;35:1473-1478.
28. Zhang L, Feng Y, List J, et al. Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: Effects on glycaemic control and body weight. Diabetes Obes Metab. 2010;12:510-516.
29. Leiter LA, Cefalu WT, De Bruin TW, et al. Dapagliflozin added to usual care in individuals with type 2 diabetes mellitus with preexisting cardiovascular disease: A 24-week, multicenter, randomized, double-blind, placebo-controlled study with a 28-week extension. J Am Geriatr Soc. 2014;62:1252-1262.
30. Matthaei S, Bowering K, Rohwedder K, et al. Dapagliflozin improves glycemic control and reduces body weight as addon therapy to metformin plus sulfonylurea: A 24-week randomized, doubleblind clinical trial. Diabetes Care. 2015;38:365-372.
31. Schafer G. On the mechanism of action of hypoglycemia-producing biguanides. A reevaluation and a molecular theory. Biochem Pharmacol. 1976;25:2005-2014.
32. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352:854-865.
33. Plosker GL. Dapagliflozin: A review of its use in type 2 diabetes mellitus. Drugs. 2012;72:2289-2312.
34. Mannucci E, Ognibene A, Cremasco F, et al. Effect of metformin on glucagonlike peptide 1 (GLP-1) and leptin levels in obese nondiabetic subjects. Diabetes Care. 2001;24:489-494.
35. Giannarelli R, Aragona M, Coppelli A, et al. Reducing insulin resistance with metformin: The evidence today. Diabetes Metab. 2003;29:S28-S35.
36. Chang M, Liu X, Cui D, et al. Bioequivalence, food effect, and steadystate assessment of dapagliflozin/metformin extended-release fixed-dose combination tablets relative to single-component dapagliflozin and metformin extendedrelease tablets in healthy subjects. Clin Ther. 2015;37:1517-1528.
37. Kasichayanula S, Liu X, Shyu WC, et al. Lack of pharmacokinetic interaction between dapagliflozin, a novel sodiumglucose transporter 2 inhibitor, and metformin, pioglitazone, glimepiride or sitagliptin in healthy subjects. Diabetes Obes Metab. 2011;13:47-54.
38. AstraZeneca. Xigduo(dapagliflozin/metformin filmcoated tablets): US prescribing information [Internet]. 2015. Available from: Http://www.accessdata.fda.gov/drug satfda-docs/label/2014/205649s000lbl.pdf
39. Henry RR, Murray AV, Marmolejo MH, et al. Dapagliflozin, metformin XR, or both: Initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012;66:446-456.
40. Bolinder J, Ljunggren Ö, Johansson L, et al. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014;16:159-169.
41. Ljunggren Ö, Bolinder J, Johansson L, et al. Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin. Diabetes Obes Metab. 2012;14:990-999.
42. 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;37:740-750.
43. Rosenstock J, Hansen L, Zee P, et al. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: A randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care. 2015;38:376-383.
44. Del Prato S, Nauck M, Durán-Garcia S, et al. Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. Diabetes Obes Metab. 2015;17:581-590.
45. Schumm-Draeger PM, Burgess L, Korányi L, et al. Twice-daily dapagliflozin coadministered with metformin in type 2 diabetes: A 16-week randomized, placebocontrolled clinical trial. Diabetes Obes Metab. 2015;17:42-51.
46. Derosa G, Maffioli P. Effects of thiazolidinediones and sulfonylureas in patients with diabetes. Diabetes Technol Ther. 2010;12:491-501.
47. Lorber D. Importance of cardiovascular disease risk management in patients with type 2 diabetes mellitus. Diabetes Metab Syndr Obes. 2014;7:169-183.
48. AstraZeneca. Multicenter trial to evaluate the effect of dapagliflozin on the incidence of cardiovascular events (clinicaltrials.gov identifier: NCT01730534) [Internet]. 2012 [cited 2015 Sep 14]. Available from: Https://clinicaltrials.gov/ct2/show/NCT01730534?term= NCT01730534&rank=1.
49. Chaplin S, McCourt C, Joseph F. Xigduo: Dapagliflozin plus metformin for T2DM. Prescriber. 2014;25:36-38.
50. Lambers Heerspink HJ, De Zeeuw D, Wie L, et al. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013;15:853-862.
51. Ho PM, Rumsfeld JS, Masoudi FA, et al. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006;166:1836-1841.
52. Zinman B. Initial combination therapy for type 2 diabetes mellitus: Is it ready for prime time? Am J Med. 2011;124: S19-S34.
53. Fu AZ, Qiu Y, Davies MJ, et al. Treatment intensification in patients with type 2 diabetes who failed metformin monotherapy. Diabetes Obes Metab. 2011;13:765-769.
54. Engel SS, Seck TL, Golm GT, et al. Assessment of AACE/ACE recommendations for initial dual antihyperglycemic therapy using the fixed-dose combination of sitagliptin and metformin versus metformin. Endocr Pract. 2013;19:751-757.
55. Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care. 2012;35:2650-2664.
56. American Diabetes Association. Diabetes statistics [Internet]. [cited 2014 Apr 10]. Available from: Http://www.diabetes.org/diabetes-basics/statistics/?loc=superfooter.
57. Freeman JS, Gross B. Potential drug interactions associated with treatments for type 2 diabetes and its comorbidities: A clinical pharmacology review. Expert Rev Clin Pharmacol. 2012;5:31-42.