Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: A randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase

Expert Opinion on Pharmacotherapy

Volumn 15, Issue 15, 2014, Pages 2121-2130

  Kaku, Kohei ^a   Mori, Mikiko ^b   Kanoo, Tatsuhiro ^b   Katou, Masafumi ^b   Seino, Yutaka ^c  

^a KAWASAKI MEDICAL SCHOOL   (Japan)

^b TAKEDA PHARMACEUTICAL COMPANY LIMITED   (Japan)

^c KANSAI ELECTRIC POWER CO   (Japan)

Author keywords

Alogliptin; Clinical trial; Insulin; Japanese patients; Type 2 diabetes mellitus

Indexed keywords

ALOGLIPTIN; HEMOGLOBIN A1C; INSULIN; PLACEBO; ANTIDIABETIC AGENT; DRUG DERIVATIVE; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; PIPERIDINE DERIVATIVE; URACIL;

ACUTE HEPATITIS; ADD ON THERAPY; ADULT; ARTICLE; BACKACHE; CONSTIPATION; CONTROLLED STUDY; DIABETIC PATIENT; DIET THERAPY; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECZEMA; FEMALE; GASTROENTERITIS; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INFLUENZA; INSULIN TREATMENT; JAPANESE (PEOPLE); KINESIOTHERAPY; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; PHARYNGITIS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; WEIGHT GAIN; AGED; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; DRUG EFFECT; GLUCOSE BLOOD LEVEL; JAPAN; JAPANESE PATIENTS; PLACEBO EFFECT;

ALOGLIPTIN; CLINICAL TRIAL; INSULIN; JAPANESE PATIENTS; TYPE 2 DIABETES MELLITUS;

AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; JAPAN; MALE; MIDDLE AGED; PIPERIDINES; PLACEBO EFFECT; URACIL; WEIGHT GAIN;

EID: 84907264647     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2014.956722     Document Type: Article

References (19)

1. The Japan Diabetes Society, editor. Treatment guide for diabetes. Bunkodo. 2010
2. Kanatsuka A, Kawai K, Hirao K, et al. Research on antihyperglycemic drug therapies in patients with type 2 diabetes mellitus in Japan (II): the effectiveness on glycemic control (JDDM 7). J Japan Diabetes Soc 2006;49:919-27
3. Kanatsuka A, Kawai K, Hirao K, et al. Survey of drug therapy in type 2 diabetes mellitus (V). Combined treatment with insulin plus an oral hypoglycemic agents: clinical aspects and glycemic control (JDDM 19). J Japan Diabetes Soc 2010;53:737-44
4. Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology 2007;132:2131-57
5. Seino Y, Fukushima M, Yabe D. GIP and GLP-1, the two incretin hormones: similarities and differences. J Diabetes Investig 2010;1:8-23
6. Seino Y, Yabe D. Glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1: incretin actions beyond the pancreas. J Diabetes Investig 2013;4:108-30
7. Campbell JE, Drucker DJ. Pharmacology, physiology, and mechanisms of incretin hormone action. Cell Metab 2013;17:819-37
8. Seino Y, Yabe D. Alogliptin benzoate for the treatment of type 2 diabetes. Expert Opin Pharmacother 2014;15:851-63
9. Seino Y, Fujita T, Hiroi S, et al. Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study. Curr Med Res Opin 2011;27:1781-92
10. Cox ME, Rowell J, Corsino L, Green JB. Dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes: safety, tolerability, and efficacy. Drug Healthc Patient Saf 2010;2:7-19
11. Rosenstock J, Rendell MS, Gross JL, et al. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab 2009;11:1145-52
12. Kashiwagi A, Kasuga M, Araki E, et al. International clinical harmonization of glycated hemoglobin in Japan: From Japan Diabetes Society to National Glycohemoglobin Standardization Program values. J Diabetes Investig 2012;3:39-40
13. Nauck MA, Ellis GC, Fleck PR, et al. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract 2009;63:46-55
14. Seino Y, Miyata Y, Hiroi S, et al. Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, doubleblind, placebo-controlled trial with an open-label, long-term extension study. Diabetes Obes Metab 2012;14:927-36
15. Pratley RE, Kipnes MS, Fleck PR, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab 2009;11:167-76
16. Seino Y, Hiroi S, Hirayama M, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Investig 2012;3:517-25
17. Pratley RE, Reusch JE, Fleck PR, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 2009;25:2361-71
18. Kaku K, Itayasu T, Hiroi S, et al. Efficacy and safety of alogliptin added to pioglitazone in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label long-term extension study. Diabetes Obes Metab 2011;13:1028-35
19. Seino Y, Fujita T, Hiroi S, et al. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebocontrolled trial with an open-label, long-term extension. Curr Med Res Opin 2011;27(Suppl 3):21-9