A Phase 2/3, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Alfa-glucosidase Inhibitor in Subjects With Type 2 Diabetes in Japan

Takeda Pharmaceutical Company Limited0 个研究点目标入组 210 人开始时间: 待定

试验速览

暂无简介。

•Had been receiving as table dose and regimen of an Alfa-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase.
•Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4).
•Had HbA1c differences within 10.0% at the start of the screening phase (Week - 8 ) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase.
•Was receiving as pecific diet therapy and an exercise therapy ( if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).

•Had received any antidiabetic drug other than Alfa-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.

Change from Baseline in Glycosylated Hemoglobin (Week 12) Baseline and Week 12

Glycosylated Hemoglobin(Baseline and Weeks 2, 4, 6, 8 and 12)
Fasting Plasma Glucose(Baseline and Weeks 2, 4, 6, 8 and 12)
Fasting C-peptide(Baseline and Weeks 2, 4, 6, 8 and 12)
Blood Glucose Insulin(Baseline and Weeks 2, 4, 6, 8 and 12)
Insulin(Baseline and Weeks 2, 4, 6, 8 and 12)
C-peptide(Baseline and Weeks 2, 4, 6, 8 and 12)
Glucagons(Baseline and Weeks 2, 4, 6, 8 and 12)

发起方