A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 3
- 主要终点
- Change in HbA1c in Subjects With Type 2 DM
研究概览
简要总结
This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.
详细描述
This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly OPK-88003 in subjects with T2DM. The trial consists of a screening/baseline (up to 2 weeks prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target dose (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo administered QW.
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, 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
- •Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day),
- •BMI ≥27 and ≤45 kg/m2
- •HbA1c ≥7.0% and ≤10.5% at screening
排除标准
- •Type 1 diabetes mellitus
- •Previous treatment with incretin mimetic drugs
- •Have used insulin for diabetic control for more than 6 consecutive days within the prior year
- •Have had two or more emergency room visits or hospitalizations due to poor glucose control within the prior 6 months
- •Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (>2 x ULN).
研究组 & 干预措施
Placebo
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
干预措施: Placebo (Drug)
OPK-88003
70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks)
干预措施: OPK-88003 (Drug)
结局指标
主要结局
Change in HbA1c in Subjects With Type 2 DM
时间窗: From baseline to 30 weeks
To evaluate the effect of dose escalation of QW SC OPK-88003 vs placebo injections on HbA1c absolute change from baseline to after 30 weeks treatment in subjects with T2DM inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.
次要结局
- Mean Percent (%) Body Weight Change(From baseline to 30 weeks)
- Percent (%) of Subjects With 5% or Greater Body Weight Loss.(30 weeks.)
- Change From Baseline of Fasting Plasma Glucose (FPG).(30 weeks.)