Randomized, double‐blind, phase III study to evaluate the efficacy and safety of once‐daily treatment with alogliptin and metformin hydrochloride in Japanese patients with type 2 diabetes
نویسندگان
چکیده
This randomized, double-blind, phase III study evaluated the efficacy and safety of once-daily treatment with alogliptin (25 mg once daily), alone or with metformin hydrochloride (500 mg once daily or 250 mg twice daily), in Japanese patients with type 2 diabetes. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to the end of treatment (week 24). The least squares (LS) mean (standard error) change in HbA1c from baseline to the end of treatment (week 24) was 0.16 (0.072)% in alogliptin alone, -0.49 (0.049)% in alogliptin/metformin once daily, and -0.60 (0.049)% in alogliptin/metformin twice daily. The LS mean difference in HbA1c change from baseline between alogliptin/metformin once daily and alogliptin alone (alogliptin/metformin once daily minus alogliptin alone) was -0.65% (95% confidence interval [CI] -0.821, -0.480) and between alogliptin/metformin once daily and twice daily (once daily minus twice daily) was 0.11% (95% CI -0.026, 0.247). The overall frequency of adverse events was similar among the groups. This study showed that the efficacy of alogliptin/metformin once daily was superior to alogliptin alone and non-inferior to alogliptin/metformin twice daily, and that alogliptin/metformin once daily was safe and well tolerated in Japanese patients with type 2 diabetes.
منابع مشابه
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
AIMS/INTRODUCTION To evaluate the efficacy and safety of alogliptin added to treatment with glimepiride. MATERIALS AND METHODS This multicenter, randomized, double-blind, parallel-group, 24-week (12-week observation and 12-week treatment) study compared alogliptin 12.5 or 25 mg in combination with glimepiride (1-4 mg/day) vs placebo added to glimepiride monotherapy in Japanese patients with t...
متن کاملEfficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study.
OBJECTIVE To evaluate the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin in drug-naïve patients with inadequately controlled type 2 diabetes. RESEARCH DESIGN AND METHODS This double-blind, placebo-controlled, multicenter study included 329 patients with poorly controlled diabetes randomized to once-daily treatment with 12.5 mg alogliptin (n = 133), 25 mg alogliptin (n = 131), or placebo ...
متن کاملCynara scolymus L. in Treatment of Hypercholesterolemic Type 2 Diabetic Patients: a Randomized Double-Blind Placebo-Controlled Clinical Trial
Background: Type 2 diabetes mellitus with hyperlipidemia is a common disease. Conventional anti-hyperglycemic and anti-hyperlipidemic drugs have limited efficacies and important side effects, so that alternative agents are needed. Previous studies suggest that fiber-free artichoke (Cynara scolymus L.) leaf extract may have anti-hyperglycemic and anti-hypercholesterolemic effects in hypercholest...
متن کاملEfficacy and safety of fixed‐dose combination therapy, alogliptin plus metformin, in Asian patients with type 2 diabetes: A phase 3 trial
This study evaluated the efficacy and safety of 26 weeks of twice-daily (BID) alogliptin + metformin fixed-dose combination (FDC) therapy in Asian patients with type 2 diabetes. Patients aged 18 to 75 years with hemoglobin A1c (HbA1c) of 7.5% to 10.0% after ≥2 months of diet and exercise and a 4-week placebo run-in were enrolled. Eligible patients were randomized (1:1:1:1) to placebo, aloglipti...
متن کاملIpragliflozin in combination with metformin for the treatment of Japanese patients with type 2 diabetes: ILLUMINATE, a randomized, double-blind, placebo-controlled study
This multicenter, double-blind, placebo-controlled study examined the efficacy and safety of ipragliflozin, a sodium-glucose co-transporter 2 inhibitor, in combination with metformin in Japanese patients with type 2 diabetes mellitus (T2DM). Patients were randomized in a 2 : 1 ratio to 50 mg ipragliflozin (n = 112) or placebo (n = 56) once daily for 24 weeks, followed by a 28-week open-label ex...
متن کامل