NCT01968265已完成2 期
A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 426115 (an Antisense Glucocorticoid Receptor Antagonist) Administered Subcutaneously Once Weekly for 6 Weeks to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- The effect of ISIS-GCCRRx on serum fructosamine
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 to 75
- •BMI greater than or equal to 25
- •HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
- •Type 2 Diabetes Mellitus and on stable dose of oral metformin
- •Agree to conduct home-based (fasted) blood glucose testing as directed
排除标准
- •Clinically significant abnormalities in medical history or physical exam
- •Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
- •History of renal transplantation or renal dialysis
- •History of liver disease
- •History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
- •Use of oral anti-diabetic medication other than metformin within 3 months of screening
- •Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening
- •History of diabetic ketoacidosis
- •Current or previous diagnosis of Gilbert's disease
- •Any other significant illness or condition that may interfere with the patient participating or completing the study
- •Inability or unwillingness to comply with protocol or study procedures
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ISIS-GCCRRx
Active Comparator
干预措施: ISIS-GCCRRx (Drug)
结局指标
主要结局
The effect of ISIS-GCCRRx on serum fructosamine
时间窗: 7 Weeks
Change from Baseline to Week 7
次要结局
- The safety of ISIS-GCCRRx(18 Weeks)
- The tolerability of ISIS-GCCRRx(18 Weeks)
研究者
研究点 (2)
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