Bibliography
- Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.
- American Diabetes Association. Standards of medical care in diabetes-2015. Diabetes Care. 2015;38(Suppl. 1):S1–S49.
- 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.
- 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.
- 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.
- 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.
- 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 meta-analysis of randomised controlled trials. Lancet. 2009;373:1765–1772.
- Ismail-Beigi F. Glycemic management of type 2 diabetes mellitus. N Engl J Med. 2012;366:1319–1327.
- 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.
- Hundal RS, Krssak M, Dufour S, et al. Mechanism by which metformin reduces glucose production in type 2 diabetes. Diabetes. 2000;49:2063–2069.
- Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996;334:574–579.
- Katsiki N, Papanas N, Mikhailidis DP. Dapagliflozin: more than just another oral glucose-lowering agent? Expert Opin Investig Drugs. 2010;19:1581–1589.
- 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.
- 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.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- 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.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- 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.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- Bailey CJ, Day C. Fixed-dose single tablet antidiabetic combinations. Diabetes Obes Metab. 2009;11:527–533.
- 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.
- Hanefeld M, Bornstein SR, Barthel A. Modern medical treatment of type 2 diabetes. Dtsch Med Wochenschr. 2014;139:2494–2497.
- 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.
- 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.
- Wright EM. Renal Na(+)-glucose cotransporters. Am J Physiol Renal Physiol. 2001;280:10–18.
- 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.
- List JF, Whaley JM. Glucose dynamics and mechanistic implications of SGLT2 inhibitors in animals and humans. Kidney Int Suppl. 2011;120:S20–S27.
- 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/community-register/html/h884.htm#EndOfPage
- 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
- Farxiga® (dapagliflozin). Full prescribing information. Princeton (NJ): Bristol-Myers Squibb; 2014.
- 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.
- 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.
- 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.
- Matthaei S, Bowering K, Rohwedder K, et al. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: A 24-week randomized, double-blind clinical trial. Diabetes Care. 2015;38:365–372.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- Schafer G. On the mechanism of action of hypoglycemia-producing biguanides. A reevaluation and a molecular theory. Biochem Pharmacol. 1976;25:2005–2014.
- 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.
- Plosker GL. Dapagliflozin: a review of its use in type 2 diabetes mellitus. Drugs. 2012;72:2289–2312.
- Mannucci E, Ognibene A, Cremasco F, et al. Effect of metformin on glucagon-like peptide 1 (GLP-1) and leptin levels in obese nondiabetic subjects. Diabetes Care. 2001;24:489–494.
- Giannarelli R, Aragona M, Coppelli A, et al. Reducing insulin resistance with metformin: the evidence today. Diabetes Metab. 2003;29:S28–S35.
- Chang M, Liu X, Cui D, et al. Bioequivalence, food effect, and steady-state assessment of dapagliflozin/metformin extended-release fixed-dose combination tablets relative to single-component dapagliflozin and metformin extended-release tablets in healthy subjects. Clin Ther. 2015;37:1517–1528.
- Kasichayanula S, Liu X, Shyu WC, et al. Lack of pharmacokinetic interaction between dapagliflozin, a novel sodium-glucose transporter 2 inhibitor, and metformin, pioglitazone, glimepiride or sitagliptin in healthy subjects. Diabetes Obes Metab. 2011;13:47–54.
- AstraZeneca. Xigduo(dapagliflozin/metformin filmcoated tablets): US prescribing information [Internet]. 2015. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205649s000lbl.pdf
- 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.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- 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.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- 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.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- 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.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- 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.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- 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.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- Schumm-Draeger PM, Burgess L, Korányi L, et al. Twice-daily dapagliflozin co-administered with metformin in type 2 diabetes: a 16-week randomized, placebo-controlled clinical trial. Diabetes Obes Metab. 2015;17:42–51.
• Clinical trial on combination therapy of dapagliflozin and metformin.
- Derosa G, Maffioli P. Effects of thiazolidinediones and sulfonylureas in patients with diabetes. Diabetes Technol Ther. 2010;12:491–501.
- Lorber D. Importance of cardiovascular disease risk management in patients with type 2 diabetes mellitus. Diabetes Metab Syndr Obes. 2014;7:169–183.
- 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.
- Chaplin S, McCourt C, Joseph F. Xigduo: dapagliflozin plus metformin for T2DM. Prescriber. 2014;25:36–38.
- 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.
- 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.
- Zinman B. Initial combination therapy for type 2 diabetes mellitus: is it ready for prime time? Am J Med. 2011;124:S19–S34.
- 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.
- 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.
- Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care. 2012;35:2650–2664.
- American Diabetes Association. Diabetes statistics [Internet]. [ cited 2014 Apr 10]. Available from: http://www.diabetes.org/diabetes-basics/statistics/?loc=superfooter.
- 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.