A Phase II, Double Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerance and Activity of HE3286 When Administered Orally for 12 Weeks to Adult Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 主要终点
- To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.
研究概览
简要总结
This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks.
详细描述
Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes. The investigational drug, HE3286, holds the potential to be the first in a new class of insulin sensitizers with a potentially novel mechanism of action that may improve the current therapeutic options available to a T2DM patient.
This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks. Changes in hemoglobin A1c (HbA1c) will be assessed over a treatment period of 12-weeks.
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
- 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
- •Patient with a diagnosis of Type 2 Diabetes Mellitus (T2DM)
- •Patient must be a) on a stable dose of metformin as monotherapy for at least 10 weeks prior to screening; or b) drug-naive, defined as never having received drug treatment for T2DM or not having received antidiabetic drug therapy during the 3 months prior to screening.
- •Patient with a fasting blood glucose level of ≤ 225 mg/dL at screening (≤ 255 mg/dl for drug-naive patients);
- •Patient with HbA1c levels >7.5% (7.0 - 10.5% for drug-naive patients) at screening;
- •Patient with BMI 28-37 kg/m2 for females 28-39 kg/m2 for males
排除标准
- •Patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities within 6 months prior to screening;
- •Patient with unstable diabetic complications requiring treatment or ongoing active intervention;
- •Patient with a history of long term insulin therapy within the past year;
- •Patient who has had therapy with rosiglitazone, pioglitazone, exendin-4 or sitagliptin, alone or in combination within 6 months prior to screening;
- •Patient who has any clinically significant abnormalities in laboratory results at screening;
研究组 & 干预措施
Placebo
Placebo capsules BID
干预措施: Placebo (Drug)
Active
HE3286 10 mg (5 mg BID)
干预措施: HE3286 (Drug)
结局指标
主要结局
To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.
时间窗: 12-weeks
To evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12.
时间窗: 12-weeks
次要结局
- To evaluate the effect of HE3286 on insulin sensitivity over time.(12-weeks)
- To evaluate the effect of HE3286 on fasting blood glucose over time.(12-weeks)