Saxagliptin plus metformin combination therapy

Expert Review of Endocrinology and Metabolism

Volumn 7, Issue 2, 2012, Pages 151-164

  Scheen, André J ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

DPP 4 inhibitor; fixed dose combination; metformin; saxagliptin; Type 2 diabetes mellitus

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALOGLIPTIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GASTRIC INHIBITORY POLYPEPTIDE; GLIPIZIDE; GLITAZONE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C; INSULIN; LINAGLIPTIN; LIRAGLUTIDE; METFORMIN; METFORMIN PLUS SAXAGLIPTIN; METFORMIN PLUS SITAGLIPTIN; METFORMIN PLUS VILDAGLIPTIN; PIOGLITAZONE; PLACEBO; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA; VILDAGLIPTIN;

ABDOMINAL PAIN; ADD ON THERAPY; ARTICLE; BLOOD GLUCOSE METER; BLOOD GLUCOSE MONITORING; CLINICAL TRIAL (TOPIC); CONTROLLED CLINICAL TRIAL (TOPIC); DIARRHEA; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG MEGADOSE; DRUG TOLERANCE; DYSLIPIDEMIA; FIBRINOLYSIS; GASTROINTESTINAL DISEASE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HORMONE ACTION; HUMAN; HYPOGLYCEMIA; KIDNEY FAILURE; LACTIC ACIDOSIS; LIFESTYLE MODIFICATION; MULTICENTER STUDY (TOPIC); NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREATITIS; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; SINGLE DRUG DOSE; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION;

EID: 84858017601     PISSN: 17446651     EISSN: 17448417     Source Type: Journal    
DOI: 10.1586/eem.11.98     Document Type: Article

References (69)

1. De Fronzo RA. Banting lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of Type 2 diabetes mellitus. Diabetes 58, 773-795 (2009).
2. American Diabetes Association. Standards of medical care in diabetes - 2011. Diabetes Care 34(Suppl. 1), S11-S61 (2011).
3. Nyenwe EA, Jerkins TW, Umpierrez GE et al. Management of Type 2 diabetes: evolving strategies for the treatment of patients with Type 2 diabetes. Metabolism 60, 1-23 (2011).
4. Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycaemia in Type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 52, 17-30 (2009).
5. Bennett WL, Maruthur NM, Singh S et al. Comparative effectiveness and safety of medications for Type 2 diabetes: an update including new drugs and 2-drug combinations. Ann. Intern. Med. 154, 602-613 (2011).
6. Rodbard HW, Jellinger PS, Davidson JA et al. Statement by an American Association of clinical endocrinologists/ American college of endocrinology consensus panel on Type 2 diabetes mellitus: an algorithm for glycemic control. Endocr. Pract. 15, 540-559 (2009).
7. Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in Type 2 diabetes. Lancet 368, 1696-1705 (2006).
8. Gallwitz B. GLP-1 agonists and dipeptidylpeptidase IV inhibitors. Handb. Exp. Pharmacol. 203, 53-74 (2011).
9. Scheen AJ. A review of gliptins in 2011. Exp. Opin. Pharmacother. 13, 81-99 (2012).
10. Scheen AJ. DPP-4 inhibitors in the management of Type 2 diabetes : a critical review of head-to-head trials. Diabetes Metab. doi:10.1016/j.diabet. 2011.11.001 (2011) (Epub ahead of print).
11. Hollander PA, Kushner P. Type 2 diabetes comorbidities and treatment challenges: rationale for DPP-4 inhibitors. Postgrad. Med. 122, 71-80 (2010).
12. Ahren B, Foley JE, Bosi E. Clinical evidence and mechanistic basis for vildagliptin's action when added to metformin. Diabetes Obes. Metab. 13, 193-203 (2011).
13. Derosa G, Maffioli P. Patient considerations and clinical utility of a fixed dose combination of saxagliptin/metformin in the treatment of Type 2 diabetes. Diabetes Metab. Syndr. Obes. 4, 263-271 (2011).
14. Scheen AJ. Pharmacokinetic and pharmacodynamic evaluation of sitagliptin plus metformin. Expert Opin. Drug Metab. Toxicol. 6, 1265-1276 (2010).
15. Halimi S, Schweizer A, Minic B et al. Combination treatment in the management of Type 2 diabetes: focus on vildagliptin and metformin as a single tablet. Vasc. Health Risk Manag. 4, 481-492 (2008).
16. Saxagliptin/metformin (kombiglyze XR) for Type 2 diabetes. Med. Lett. Drugs Therapeut. 53, 21-22 (2011).
17. Scheen AJ. Metformin + saxagliptin for Type 2 diabetes. Expert Opin. Pharmacother. 13, 139-146 (2012).
18. Neumiller JJ, Campbell RK. Saxagliptin: a dipeptidyl peptidase-4 inhibitor for the treatment of Type 2 diabetes mellitus. Am. J. Health Syst. Pharm. 67, 1515-1525 (2010).
19. Dhillon S, Weber J. Saxagliptin. Drugs 69, 2103-2114 (2009).
20. Kania DS, Gonzalvo JD, Weber ZA. Saxagliptin: a clinical review in the treatment of Type 2 diabetes mellitus. Clin. Ther. 33, 1005-1022 (2011).
21. Stumvoll M, Nurjhan N, Perriello G et al. Metabolic effects of metformin in non-insulin-dependent diabetes mellitus. N. Engl. J. Med. 333, 550-554 (1995).
22. Hundal RS, Inzucchi SE. Metformin: new understandings, new uses. Drugs 63, 1879-1894 (2003).
23. Setter SM, Iltz JL, Thams J et al. Metformin hydrochloride in the treatment of Type 2 diabetes mellitus: a clinical review with a focus on dual therapy. Clin. Ther. 25, 2991-3026 (2003).
24. Consoli A, Gomis R, Halimi S et al. Initiating oral glucose-lowering therapy with metformin in Type 2 diabetic patients: an evidence-based strategy to reduce the burden of late-developing diabetes complications. Diabetes Metab. 30, 509-516 (2004).
25. Anfossi G, Russo I, Bonomo K et al. The cardiovascular effects of metformin: further reasons to consider an old drug as a cornerstone in the therapy of Type 2 diabetes mellitus. Curr. Vasc. Pharmacol. 8, 327-337 (2010).
26. Messaoudi SE, Rongen GA, de Boer RA et al. The cardioprotective effects of metformin. Curr. Opin. Lipidol. 22, 445-453 (2011).
27. Decensi A, Puntoni M, Goodwin P et al. Metformin and cancer risk in diabetic patients: a systematic review and meta-analysis. Cancer Prev. Res. (Phila.) 3, 1451-1461 (2010).
28. Migoya EM, Bergeron R, Miller JL et al. Dipeptidyl peptidase-4 inhibitors administered in combination with metformin result in an additive increase in the plasma concentration of active GLP-1. Clin. Pharmacol. Ther. 88, 801-808 (2010).
29. Krentz AJ, Patel MB, Bailey CJ. New drugs for Type 2 diabetes mellitus: what is their place in therapy? Drugs 68, 2131-2162 (2008).
30. Henry RR, Smith SR, Schwartz SL et al. Effects of saxagliptin on b-cell stimulation and insulin secretion in patients with Type 2 diabetes. Diabetes Obes. Metab. 13, 850-858 (2011).
31. Phung OJ, Scholle JM, Talwar M et al. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in Type 2 diabetes. JAMA 303, 1410-1418 (2010).
32. Scheen AJ. Clinical pharmacokinetics of metformin. Clin. Pharmacokinet. 30, 359-371 (1996).
33. Graham GG, Punt J, Arora M et al. Clinical pharmacokinetics of metformin. Clin. Pharmacokinet. 50, 81-98 (2011).
34. Scheen AJ. Pharmacokinetics of dipeptidylpeptidase-4 inhibitors. Diabetes Obes. Metab. 12, 648-658 (2010).
35. Boulton DW, Li L, Frevert EU et al. Influence of renal or hepatic impairment on the pharmacokinetics of saxagliptin. Clin. Pharmacokinet. 50, 253-265 (2011).
36. Scheen AJ. Drug interactions of clinical importance with antihyperglycaemic agents - an update. Drug Safety 28, 601-631 (2005).
37. Baetta R, Corsini A. Pharmacology of dipeptidyl peptidase-4 inhibitors: similarities and differences. Drugs 71, 1441-1467 (2011).
38. Scheen AJ. Dipeptidylpeptidase-4 inhibitors (gliptins): focus on drug-drug interactions. Clin. Pharmacokinet. 49, 573-588 (2010).
39. Scheen AJ. Cytochrome P450-mediated cardiovascular drug interactions. Expert Opin. Drug Metab. Toxicol. 7, 1065-1082 (2011).
40. Patel CG, Kornhauser D, Vachharajani N et al. Saxagliptin, a potent, selective inhibitor of DPP-4, does not alter the pharmacokinetics of three oral antidiabetic drugs (metformin, glyburide or pioglitazone) in healthy subjects. Diabetes Obes. Metab. 13, 604-614 (2011).
41. Jabbour S, Ziring B. Advantages of extended-release metformin in patients with Type 2 diabetes mellitus. Postgrad. Med. 123, 15-23 (2011).
42. Boulton DW, Smith CH, Li L et al. Bioequivalence of saxagliptin/metformin extended-release (XR) fixed-dose combination tablets and single-component saxagliptin and metformin XR tablets in healthy adult subjects. Clin. Drug Investig. 31, 619-630 (2011).
43. He YL, Paladini S, Sabia H et al. Bioequivalence of vildagliptin/ metformin fixed-dose combination tablets and a free combination of vildagliptin and metformin in healthy subjects. Int. J. Clin. Pharmacol. Ther. 46, 259-267 (2008).
44. Reynolds JK, Neumiller JJ, Campbell RK. Janumet: a combination product suitable for use in patients with Type 2 diabetes. Expert Opin. Investig. Drugs 17, 1559-1565 (2008).
45. Stenlof K, Raz I, Neutel J et al. Saxagliptin and metformin XR combination therapy provides glycemic control over 24 hours in patients with T2DM inadequately controlled with metformin. Curr. Med. Res. Opin. 26, 2355-2363 (2010).
46. DeFronzo RA, Hissa MN, Garber AJ et al. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled Type 2 diabetes with metformin alone. Diabetes Care 32, 1649-1655 (2009).
47. DeFronzo R, Hissa M, Garber A et al. Once-daily saxagliptin added to metformin provides sustained glycemic control and is well tolerated over 102 weeks in patients with T2D. Diabetes 58, A147, 547-P (2009).
48. Yang W, Pan CY, Tou C et al. Efficacy and safety of saxagliptin added to metformin in Asian patients with Type 2 diabetes mellitus: A randomized controlled trial. Diabetes Res. Clin. Pract. 94, 217-224 (2011).
49. Gautier JF, Sauvanet JP. Efficacy of saxagliptin as an add-on to oral monotherapy in the Phase 3 clinical development program: Predictive factors of the treatment response in Type 2 diabetes. Ann. Endocrinol. (Paris) 72, 287-295 (2011).
50. Goke B, Gallwitz B, Eriksson J et al. Saxagliptin is non-inferior to glipizide in patients with Type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial. Int. J. Clin. Pract. 64, 1619-1631 (2010).
51. Göke B, Gallwitz B, Eriksson J et al. Saxagliptin vs glipizide as add-on to metformin for Type 2 diabetes mellitus (T2DM): long-term safety and efficacy. Diabetes 60(Suppl. 1), Abstract 1110-P (2011).
52. Allen E, Berglind N. Saxagliptin vs glipizide as add-on therapy to metformin in patients with Type 2 diabetes: a 2-year assessment of HbA1c, hypoglycaemia, and weight gain in a randomised, double-blind study. Diabetologia 54(Suppl. 1), S337, 827 (2011).
53. Scheen AJ, Charpentier G, Ostgren CJ et al. Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with Type 2 diabetes mellitus. Diabetes Metab. Res. Rev. 26, 540-549 (2010).
54. Fonseca V, Zhu T, Karyekar C, Hirshberg B. Adding saxagliptin to extended-release metformin vs. uptitrating metformin dosage. Diabetes Obes. Metab. doi:10.1111/j.1463-1326.2011.01553.x (2011) (Epub ahead of print).
55. Hermans MP, Delibasi T, Farmer I et al. Effects of saxagliptin added to submaximal doses of metformin compared with dose escalation of metformin in Type 2 diabetes: results from the PROMPT study. Diabetologia 54 (Suppl. 1), S337, 828 (2011).
56. Jadzinsky M, Pfutzner A, Paz-Pacheco E et al. Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with Type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes Obes. Metab. 11, 611-622 (2009).
57. Pfutzner A, Paz-Pacheco E, Allen E et al. Initial combination therapy with saxagliptin and metformin provides sustained glycaemic control and is well tolerated for up to 76 weeks. Diabetes Obes. Metab. 13, 567-576 (2011).
58. Charbonnel B, Barnett AH, Donovan M et al. Saxagliptin (SAXA) add-on therapy improves glycemic control in patients (pts) with poorly controlled Type 2 diabetes (T2D) on insulin (INS) alone or INS combined with metformin (MET). Diabetes 60(Suppl. 1), Abstract 1108-P (2011).
59. 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. Diabetologia 54(Suppl. 1), S108-S109, 243 (2011).
60. Bailey CJ, Day C. Fixed-dose single tablet antidiabetic combinations. Diabetes Obes. Metab. 11, 527-533 (2009)
61. Rozenfeld Y, Hunt JS, Plauschinat C et al. Oral antidiabetic medication adherence and glycemic control in managed care. Am. J. Manag. Care 14, 71-75 (2008).
62. 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. 27, 1157-1168 (2011).
63. Yang LPH. Saxagliptin. A review of its use as combination therapy in the management of Type 2 diabetes mellitus. Drugs 72(2), 229-248 (2011).
64. Senior PA. Type 2 diabetes, metformin and lactic acidosis-defining the risk and promoting safe practice. Diabet Med. 29(2), 161-163 (2011).
65. Lipska KJ, Bailey CJ, Inzucchi SE. Use of metformin in the setting of mild-tomoderate renal insufficiency. Diabetes Care 34, 1431-1437 (2011).
66. Roussel R, Travert F, Pasquet B et al. Metformin use and mortality among patients with diabetes and atherothrombosis. Arch. Intern. Med. 170, 1892-1899 (2010).
67. Frederich R, Alexander JH, Fiedorek FT et al. A systematic assessment of cardiovascular outcomes in the saxagliptin drug development program for Type 2 diabetes. Postgrad. Med. 122, 16-27 (2010).
68. Butler PC, Matveyenko AV, Dry S et al Glucagon-like peptide-1 therapy and the exocrine pancreas: innocent bystander or friendly fire? Diabetologia 53, 1-6 (2010).
69. Scheen AJ. DPP-4 inhibitors are favourable to GLP-1 receptor agonists: yes. Eur. J. Intern. 23(2), 126-231 (2011).