A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Metformin in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 527
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus.
详细描述
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.
The aim of the current study is to evaluate the effectiveness of alogliptin in combination with metformin in individually who are inadequately controlled on metformin alone.
Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Alogliptin 12.5 mg QD
干预措施: Alogliptin and metformin (Drug)
Alogliptin 25 mg QD
干预措施: Alogliptin and metformin (Drug)
Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
时间窗: Baseline and Week 26.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (Week 4).(Baseline and Week 4.)
- Change From Baseline in Glycosylated Hemoglobin (Week 8).(Baseline and Week 8.)
- Change From Baseline in Glycosylated Hemoglobin (Week 12).(Baseline and Week 12.)
- Change From Baseline in Glycosylated Hemoglobin (Week 16).(Baseline and Week 16.)
- Change From Baseline in Glycosylated Hemoglobin (Week 20).(Baseline and Week 20.)
- Change From Baseline in Fasting Plasma Glucose (Week 1).(Baseline and Week 1.)
- Change From Baseline in Fasting Plasma Glucose (Week 2).(Baseline and Week 2.)
- Change From Baseline in Fasting Plasma Glucose (Week 4).(Baseline and Week 4.)
- Change From Baseline in Fasting Plasma Glucose (Week 8).(Baseline and Week 8.)
- Change From Baseline in Fasting Plasma Glucose (Week 12).(Baseline and Week 12.)
- Change From Baseline in Fasting Plasma Glucose (Week 16).(Baseline and Week 16.)
- Change From Baseline in Fasting Plasma Glucose (Week 20).(Baseline and Week 20.)
- Change From Baseline in Fasting Plasma Glucose (Week 26).(Baseline and Week 26.)
- Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).(26 Weeks.)
- Number of Participants Requiring Rescue.(26 Weeks.)
- Change From Baseline in Fasting Proinsulin (Week 4).(Baseline and Week 4.)
- Change From Baseline in Fasting Proinsulin (Week 8).(Baseline and Week 8.)
- Change From Baseline in Fasting Proinsulin (Week 12).(Baseline and Week 12.)
- Change From Baseline in Fasting Proinsulin (Week 16).(Baseline and Week 16.)
- Change From Baseline in Fasting Proinsulin (Week 20).(Baseline and Week 20.)
- Change From Baseline in Fasting Proinsulin (Week 26).(Baseline and Week 26.)
- Change From Baseline in Insulin (Week 4).(Baseline and Week 4.)
- Change From Baseline in Insulin (Week 8).(Baseline and Week 8.)
- Change From Baseline in Insulin (Week 12).(Baseline and Week 12.)
- Change From Baseline in Insulin (Week 16).(Baseline and Week 16.)
- Change From Baseline in Insulin (Week 20).(Baseline and Week 20.)
- Change From Baseline in Insulin (Week 26).(Baseline and Week 26.)
- Change From Baseline in Proinsulin/Insulin Ratio (Week 4).(Baseline and Week 4.)
- Change From Baseline in Proinsulin/Insulin Ratio (Week 8).(Baseline and Week 8.)
- Change From Baseline in Proinsulin/Insulin Ratio (Week 12).(Baseline and Week 12.)
- Change From Baseline in Proinsulin/Insulin Ratio (Week 16).(Baseline and Week 16.)
- Change From Baseline in Proinsulin/Insulin Ratio (Week 20).(Baseline and Week 20.)
- Change From Baseline in Proinsulin/Insulin Ratio (Week 26).(Baseline and Week 26.)
- Change From Baseline in C-peptide (Week 4).(Baseline and Week 4.)
- Change From Baseline in C-peptide (Week 8).(Baseline and Week 8.)
- Change From Baseline in C-peptide (Week 12).(Baseline and Week 12.)
- Change From Baseline in C-peptide (Week 16).(Baseline and Week 16.)
- Change From Baseline in C-peptide (Week 20).(Baseline and Week 20.)
- Change From Baseline in C-peptide (Week 26).(Baseline and Week 26.)
- Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.(Baseline and Week 26.)
- Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.(Baseline and Week 26.)
- Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.(Baseline and Week 26.)
- Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.(Baseline and Week 26.)
- Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.(Baseline and Week 26.)
- Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.(Baseline and Week 26.)
- Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.(Baseline and Week 26.)
- Change From Baseline in Body Weight (Week 8).(Baseline and Week 8.)
- Change From Baseline in Body Weight (Week 12).(Baseline and Week 12.)
- Change From Baseline in Body Weight (Week 20).(Baseline and Week 20.)
- Change From Baseline in Body Weight (Week 26).(Baseline and Week 26.)