A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of Once Weekly RO5095932 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Change in hemoglobin A1c (HbA1c)
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-65 years of age
- •females who are either surgically sterile or post-menopausal
- •type 2 diabetes treated with a stable dose of metformin
- •BMI between 25-39kg/m2
- •HbA1c between 7 and 10%
- •fasting plasma glucose between 7 and 13.3mmol/L
排除标准
- •history of clinically significant cardiovascular disease
- •history of clinically significant hepatic or renal disease or impairment
- •recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors
研究组 & 干预措施
2placebo
干预措施: placebo (Drug)
1active
干预措施: RO5095932 (Drug)
1active
干预措施: metformin (Drug)
1placebo
干预措施: metformin (Drug)
1placebo
干预措施: placebo (Drug)
2active
干预措施: RO5095932 (Drug)
2active
干预措施: metformin (Drug)
2placebo
干预措施: metformin (Drug)
结局指标
主要结局
Change in hemoglobin A1c (HbA1c)
时间窗: from baseline to week 6
Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs
时间窗: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
次要结局
- Pharmacokinetics: blood concentration of RO5095932 after multiple dosing(multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up)
- Change in metabolic parameters: glucose, insulin, C-peptide(assessed after 4 or 6 weeks on study treatment)