A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of 17 Weeks of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
研究概览
简要总结
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.
详细描述
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.
Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.
CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18 to 70 years of age, inclusive
- •Body mass index of 27 to 45 kg/m2
- •Diagnosed with T2DM for at least 6 months before screening
- •Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
- •FPG ≤240 mg/dL at screening
- •HbA1c ≥7.0% and ≤11% at screening
- •A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval
排除标准
- •Pregnant or breastfeeding women
- •Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
- •Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
- •Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
- •Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
- •Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening
研究组 & 干预措施
Arm 1 - Weekly CJC-1134-PC
干预措施: CJC-1134-PC Injection (Drug)
Arm 2 - Weekly CJC-1134-PC
干预措施: CJC-1134-PC Injection (Drug)
Arm 3 - Weekly CJC-1134-PC
干预措施: CJC-1134-PC Injection (Drug)
Arm 4 - Weekly CJC-1134-PC
干预措施: CJC-1134-PC Injection (Drug)
Arm 5 - Weekly Placebo
干预措施: Weekly placebo for CJC-1134-PC Injection (Drug)
结局指标
主要结局
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
时间窗: CFB to Week 18
次要结局
- Time to Hyperglycemia Rescue(18 weeks)
- Fasting Body Weight CFB to Week 18(CFB to Week 18)