Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin compared with alpha-glucosidase inhibitor in Japanese patients with type 2 diabetes inadequately controlled on metformin or pioglitazone alone (Study for an Ultimate Combination Therapy to Control Diabetes with Sitagliptin-1): A multicenter, randomized, open-label, non-inferiority trial

Journal of Diabetes Investigation

Volumn 6, Issue 2, 2015, Pages 182-191

  Yokoh, Hidetaka ^a,b   Kobayashi, Kazuki ^a,b   Sato, Yasunori ^b   Takemoto, Minoru ^a,b   Uchida, Daigaku ^c   Kanatsuka, Azuma ^d   Kuribayashi, Nobuichi ^e   Terano, Takashi ^f   Hashimoto, Naotake ^g   Sakurai, Kenichi ^a,b   Hanaoka, Hideki ^b   Ishikawa, Ko ^a,b   Onishi, Shunichiro ^a,b   Yokote, Koutaro ^a,b  

^a CHIBA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b CHIBA UNIVERSITY HOSPITAL   (Japan)

^c Hotaruno Central Clinic   (Japan)

^d Chiba Central Medical Center   (Japan)

^e Misaki Naika Clinic   (Japan)

^f Chiba Aoba Municipal Hospital   (Japan)

^g TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

Author keywords

Alpha glucosidase inhibitor; Combination drug therapy; Sitagliptin

Indexed keywords

ALBUMIN; ALPHA GLUCOSIDASE INHIBITOR; ANTIHYPERTENSIVE AGENT; ANTILIPEMIC AGENT; APOLIPOPROTEIN B; C PEPTIDE; CHOLESTEROL; GLYCOALBUMIN; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LIPID; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METFORMIN; MIGLITOL; PIOGLITAZONE; SITAGLIPTIN; UNCLASSIFIED DRUG; VOGLIBOSE;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BODY WEIGHT; CHOLANGITIS; CHOLESTEROL BLOOD LEVEL; COMBINATION CHEMOTHERAPY; COMMON COLD; CONSTIPATION; CONTROLLED STUDY; DIABETES CONTROL; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIET RESTRICTION; DIZZINESS; DRUG ACTIVITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; FEMALE; FLATULENCE; GASTROINTESTINAL DISEASE; GASTROINTESTINAL SYMPTOM; HEADACHE; HEART RATE; HOMEOSTASIS; HUMAN; HYPOGLYCEMIA; ILEUS; INSULIN RESISTANCE; INTENTION TO TREAT ANALYSIS; JAPANESE (PEOPLE); LOSS OF APPETITE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OTALGIA; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STATISTICAL SIGNIFICANCE; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION;

EID: 84923651207     PISSN: 20401116     EISSN: 20401124     Source Type: Journal    
DOI: 10.1111/jdi.12282     Document Type: Article

References (46)

1. Whiting DR, Guariguata L, Weil C, et al. IDF Diabetes Atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract 2011; 94: 311-321.
2. Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 1995; 28: 103-117.
3. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837-853.
4. Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359: 1577-1589.
5. Skyler JS, Bergenstal R, Bonow RO, et al. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Circulation 2009; 119: 351-357.
6. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012; 35: 1364-1379.
7. 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.
8. Yki-Järvinen H. Thiazolidinediones. N Engl J Med 2004; 351: 1106-1118.
9. Dormandy JA, Charbonnel B, Eckland DJ, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 2005; 366: 1279-1289.
10. Turner RC, Cull CA, Frighi V, et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA 1999; 281: 2005-2012.
11. Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet 2006; 368: 1696-1705.
12. Raz I, Hanefeld M, Xu L, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia 2006; 49: 2564-2571.
13. Aschner P, Kipnes MS, Lunceford JK, et al. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care 2006; 29: 2632-2637.
14. Nonaka K, Kakikawa T, Sato A, et al. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract 2008; 79: 291-298.
15. Kanatsuka A, Kawai K, Hirao K, et al. Research on antihyperglycemic drug therapies in patients with type 2 diabetes mellitus in Japan (1): drug therapies and actual drug use. J Jpn Diabetes Soc 2006; 49: 409-915.
16. van de Laar FA, Lucassen PL, Akkermans RP, et al. Alpha-glucosidase inhibitors for patients with type 2 diabetes: results from a Cochrane systematic review and meta-analysis. Diabetes Care 2005; 28: 154-163.
17. Hanefeld M, Cagatay M, Petrowitsch T, et al. Acarbose reduces the risk for myocardial infarction in type 2 diabetic patients: meta-analysis of seven long-term studies. Eur Heart J 2004; 25: 10-16.
18. Chiasson JL, Josse RG, Gomis R, et al. Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance: the STOP-NIDDM trial. JAMA 2003; 290: 486-494.
19. Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet 2002; 359: 2072-2077.
20. Kawamori R, Tajima N, Iwamoto Y, et al. Voglibose for prevention of type 2 diabetes mellitus: a randomised, double-blind trial in Japanese individuals with impaired glucose tolerance. Lancet 2009; 373: 1607-1614.
21. Iwamoto Y, Tajima N, Kadowaki T, et al. Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial. Diabetes Obes Metab 2010; 12: 613-622.
22. Charbonnel B, Karasik A, Liu J, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care 2006; 29: 2638-2643.
23. Rosenstock J, Brazg R, Andryuk PJ, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther 2006; 28: 1556-1568.
24. Pratley RE, Nauck M, Bailey T, et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet 2010; 375: 1447-1456.
25. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31: 103-115.
26. American Diabetes Association. Standards of medical care in diabetes-2011. Diabetes Care 2011; 34(Suppl. 1): S11-S61.
27. Kadowaki T, Tajima N, Odawara M, et al. Sitagliptin added to ongoing treatment with metformin improved glycemic control and was well tolerated in Japanese patients with type 2 diabetes. In: Proceedings of the 68th ADA Scientific Sessions, San Francisco, CA, 2008; Abstract Number: 2135-PO
28. Kashiwagi A, Tajima N, Kadowaki T, et al. Sitagliptin added to ongoing treatment with pioglitazone improved glycemic control and was well tolerated in Japanese patients with type 2 diabetes. In: Proceedings of the 68th ADA Scientific Sessions, San Francisco, CA, 2008; Abstract Number: 2136-PO
29. Kobayashi K, Yokoh H, Sato Y, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin compared with α-glucosidase inhibitor in Japanese patients with type 2 diabetes inadequately controlled on sulfonylurea alone (SUCCESS-2): a multicenter, randomized, open-label, non-inferiority trial. Diabetes Obes Metab 2014; 16: 761-765.
30. Maida A, Lamont BJ, Cao X, et al. Metformin regulates the incretin receptor axis via a pathway dependent on peroxisome proliferator-activated receptor-α in mice. Diabetologia 2011; 54: 339-349.
31. 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 2010; 88: 801-808.
32. Miyazaki Y, Mahankali A, Matsuda M, et al. Effect of pioglitazone on abdominal fat distribution and insulin sensitivity in type 2 diabetic patients. J Clin Endocrinol Metab 2002; 87: 2784-2791.
33. Lamers D, Famulla S, Wronkowitz N, et al. Dipeptidyl peptidase 4 is a novel adipokine potentially linking obesity to the metabolic syndrome. Diabetes 2011; 60: 1917-1925.
34. Narita T, Katsuura Y, Sato T, et al. Miglitol induces prolonged and enhanced glucagon-like peptide-1 and reduced gastric inhibitory polypeptide responses after ingestion of a mixed meal in Japanese Type 2 diabetic patients. Diabet Med 2009; 26: 187-188.
35. Narita T, Yokoyama H, Yamashita R, et al. Comparisons of the effects of 12-week administration of miglitol and voglibose on the responses of plasma incretins after a mixed meal in Japanese type 2 diabetic patients. Diabetes Obes Metab 2012; 14: 283-287.
36. Yamanouchi T, Ogata N, Tagaya T, et al. Clinical usefulness of serum 1, 5-anhydroglucitol in monitoring glycaemic control. Lancet 1996; 347: 1514-1518.
37. Solis-Herrera C, Triplitt C, Garduno-Garcia JeJ, et al. Mechanisms of glucose lowering of dipeptidyl peptidase-4 inhibitor sitagliptin when used alone or with metformin in type 2 diabetes: a double-tracer study. Diabetes Care 2013; 36: 2756-2762.
38. Herman GA, Bergman A, Stevens C, et al. Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on incretin and plasma glucose levels after an oral glucose tolerance test in patients with type 2 diabetes. J Clin Endocrinol Metab 2006; 91: 4612-4619.
39. Pospisilik JA, Martin J, Doty T, et al. Dipeptidyl peptidase IV inhibitor treatment stimulates beta-cell survival and islet neogenesis in streptozotocin-induced diabetic rats. Diabetes 2003; 52: 741-750.
40. Ahrén B, Winzell MS, Wierup N, et al. DPP-4 inhibition improves glucose tolerance and increases insulin and GLP-1 responses to gastric glucose in association with normalized islet topography in mice with beta-cell-specific overexpression of human islet amyloid polypeptide. Regul Pept 2007; 143: 97-103.
41. Patil HR, Al Badarin FJ, Al Shami HA, et al. Meta-analysis of effect of dipeptidyl peptidase-4 inhibitors on cardiovascular risk in type 2 diabetes mellitus. Am J Cardiol 2012; 110: 826-833.
42. Lee A, Patrick P, Wishart J, et al. The effects of miglitol on glucagon-like peptide-1 secretion and appetite sensations in obese type 2 diabetics. Diabetes Obes Metab 2002; 4: 329-335.
43. Sasaki T, Shimpuku M, Kitazumi T, et al. Miglitol prevents diet-induced obesity by stimulating brown adipose tissue and energy expenditure independent of preventing the digestion of carbohydrates. Endocr J 2013; 60: 1117-1129.
44. Hucking K, Kostic Z, Pox C, et al. Alpha-Glucosidase inhibition (acarbose) fails to enhance secretion of glucagon-like peptide 1 (7-36 amide) and to delay gastric emptying in Type 2 diabetic patients. Diabet Med 2005; 22: 470-476.
45. DeLeon MJ, Chandurkar V, Albert SG, et al. Glucagon-like peptide-1 response to acarbose in elderly type 2 diabetic subjects. Diabetes Res Clin Pract 2002; 56: 101-106.
46. Horton ES, Silberman C, Davis KL, et al. Weight loss, glycemic control, and changes in cardiovascular biomarkers in patients with type 2 diabetes receiving incretin therapies or insulin in a large cohort database. Diabetes Care 2010; 33: 1759-1765.