A Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of INT131 Besylate Compared to Pioglitazone in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 64
- 主要终点
- Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
研究概览
简要总结
This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
- •Males and Females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
- •HbA1c must be ≥7.5% and ≤10% at screening
- •Fasting Plasma Glucose must be <240 mg/dL at screening
排除标准
- •History of type 1 diabetes
- •History of diabetic ketoacidosis
- •NYHA Class III or IV cardiac status or hospitalization for congestive heart failure within 6 weeks prior to Visit 1
- •Treatment with any non-peroxisome proliferator-activated receptor (non-PPAR) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
- •Treatment with rosiglitazone, pioglitazone, or any PPAR investigational antidiabetic agent within 6 month prior to screening
- •Body mass index >45 kg/m2
- •Fasting triglycerides >500 mg/dL
- •Uncontrolled hypertension (sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg
- •Presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)
研究组 & 干预措施
INT131 besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.
干预措施: INT131 besylate (Drug)
INT131 besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl
干预措施: INT131 besylate (Drug)
INT131 besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl
干预措施: INT131 besylate (Drug)
INT131 besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl
干预措施: INT131 besylate (Drug)
pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
干预措施: Pioglitazone HCl (Drug)
placebo
placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
时间窗: Weeks 0-24
HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.(Weeks 0-24)