A Phase 2 Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of MBX-102/JNJ-39659100 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 242
- 试验地点
- 34
- 主要终点
- Change in HbA1c from baseline and compared to placebo
研究概览
简要总结
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-102 at daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8 weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable dose of metformin (≥ 1500 mg/day).
详细描述
Approximately 240 patients will be randomized in this study, 60 to each of two MBX-102 treatment groups (400 and 600 mg daily), 60 to placebo, and 60 to the Actos® group. Patients in the Actos® group will receive Actos® 30 mg/daily for the first eight weeks of the treatment phase and Actos® 45 mg/daily for the last 16 weeks of the treatment phase. Patients in the MBX-102 400 mg group and MBX-102 600 mg group will continue MBX-102 400 mg and 600 mg, respectively for the full 24 weeks. All study medication will be over-encapsulated; thus, each patient will take two blinded capsules each day containing either placebo, MBX-102 or Actos®. This sample size provides the minimum number expected to ensure a power of at least 90% in detecting a difference of 0.64% in HbA1c between the placebo and experimental treatment, using a two-tailed, two-sample t-test with type 1 error of 0.05, when the pooled standard deviation is ≤ 1.0%, and the discontinuation rate is ≤ 12.5%.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
- •Male or female, 18-70 years of age
- •All female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method. Depo contraceptives are excluded.
- •Female patients must not be pregnant or lactating
- •BMI ≥ 26 (patients of Asian Indian origin ≥ 22) kg/m2
- •HbA1c ≥ 7.5%, ≤ 10.5%
- •FPG ≥ 120 mg/dL, ≤ 240 mg/dL
排除标准
- •History of diabetes secondary to pancreatitis or pancreatectomy
- •Any history of ketoacidosis
- •History of insulin use within last one year (insulin use while hospitalized is acceptable)
- •Weight loss > 10 pounds in the three months prior to screening visit
- •History of TZD use (Actos® or Avandia®) within 6 months of screening visit
- •History of TZD discontinuation due to side effect or lack of efficacy
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
MBX-102 400
干预措施: MBX-102 (Drug)
MBX-102 600
干预措施: MBX-102 (Drug)
MBX-102 400
干预措施: Metformin (Drug)
MBX-102 600
干预措施: Metformin (Drug)
Placebo
干预措施: Metformin (Drug)
Actos
30-45 mg
干预措施: Metformin (Drug)
Actos
30-45 mg
干预措施: Actos (Drug)
结局指标
主要结局
Change in HbA1c from baseline and compared to placebo
时间窗: 24 weeks
次要结局
- Change in fasting plasma glucose (FPG) from baseline and vs. placebo(24 weeks)