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.
We assessed the efficacy and safety of sitagliptin compared with α-glucosidase inhibitor (αGI) in 120 of Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on stable ≤2 mg/day glimepiride alone [mean hemoglobin A1c (HbA1c) 7.7%] by the randomized, active-controlled, non-inferiority trial. Patients were randomly assigned to receive additional sitagliptin or αGI for 24 weeks. The primary endpoint was change in HbA1c from baseline to week 12. After 12 weeks, sitagliptin reduced HbA1c by -0.44% (p < 0.001) relative to αGI. At 24 weeks, the reduction was almost identical between the groups (-0.091%, p = 0.47). Gastrointestinal disorders were more common with αGI than with sitagliptin, but only minor hypoglycaemia occurred in both groups at similar frequency. These data suggested that sitagliptin was not inferior to αGI for reduction of HbA1c in Japanese T2DM patients receiving glimepiride alone, and well tolerated with minimum risk of gastrointestinal symptoms and hypoglycaemia.
Department of Clinical Cell Biology and Medicine, Chiba University Graduate School of Medicine, Chiba, Japan; Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan; Department of Regional Disaster Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
K
K
Kobayashi
H
H
Yokoh
Y
Y
Sato
M
M
Takemoto
D
D
Uchida
A
A
Kanatsuka
N
N
Kuribayashi
T
T
Terano
N
N
Hashimoto
K
K
Sakurai
H
H
Hanaoka
K
K
Ishikawa
S
S
Onishi
K
K
Yokote
D017485:1-Deoxynojirimycin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000032:analysis; D065089:Glycoside Hydrolase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007294:Inositol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007564:Japan; D008297:Male; D008875:Middle Aged; D011719:Pyrazines / Q000009:adverse effects / Q000627:therapeutic use*; D000068900:Sitagliptin Phosphate; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000520:alpha-Glucosidases / Q000737:chemistry / Q000378:metabolism
D017485:1-Deoxynojirimycin; D054873:Dipeptidyl-Peptidase IV Inhibitors; D005765:Gastrointestinal Agents; D006442:Glycated Hemoglobin; D065089:Glycoside Hydrolase Inhibitors; D007004:Hypoglycemic Agents; D007294:Inositol; D011719:Pyrazines; D000068900:Sitagliptin Phosphate; D013453:Sulfonylurea Compounds; D014230:Triazoles; D000520:alpha-Glucosidases; C517652:hemoglobin A1c protein, human; C045621:miglitol; C057619:glimepiride; C102817:voglibose
DPP-IV inhibitor; randomized trial; sulphonylureas; type 2 diabetes; α-glucosidase inhibitor