A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets Despite Antihyperglycemic Medications
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 36
- 主要终点
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications.
详细描述
This study is a 52-week, Phase 2 trial is designed to examine whether treatment with icovamenib in participants with T2D who are currently on standard-of-care antihyperglycemic medications (metformin, SGLT2 inhibitor, alogliptin, or sitagliptin) plus lifestyle management will result in a greater reduction in HbA1c than those therapies alone. The trial investigates participants who have been on a stable dose of their antihyperglycemic medication(s) for at least 3 months prior to screening whose HbA1c remains above the target established by the American Diabetes Association (ADA).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, age ≥18 years and ≤75 years
- •Diagnosed with T2D
- •Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose for at least 3 months prior to screening (if participants are taking metformin they must be on a minimum stable dose of ≥500 mg/day)
- •Have HbA1c ≥7.5 and ≤10.5%
- •Have a BMI ≤32 kg/m2
- •Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, and must agree to the sex and contraception requirements.
- •Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.
排除标准
- •Have type 1 diabetes mellitus or a secondary form of diabetes
- •Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
- •Have positive GAD autoantibody result within 60 days prior to screening
- •Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator
- •Have personal or family history (first-degree relative) of MEN1
- •Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, [linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
- •Have fasting triglyceride ≥500 mg/dL
- •Have an eGFR <60 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
- •Have impaired liver function, defined as screening AST or ALT >1.2×ULN, and/or total bilirubin >ULN
研究组 & 干预措施
Arm B: placebo matching 100 mg
placebo matching 100mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks.
At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks
干预措施: Placebo (Drug)
Arm A: icovamenib 100 mg
icovamenib 100 mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks.
At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks
干预措施: icovamenib 100mg (Drug)
结局指标
主要结局
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
时间窗: 26 weeks
Mean change in HbA1c from baseline
次要结局
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control(12 weeks)
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control(52 weeks)
- To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period(26 weeks)
- To compare the safety and tolerability of icovamenib versus placebo(52 weeks)
- To compare the safety and tolerability of icovamenib versus placebo(16 weeks)
- To compare the safety and tolerability of icovamenib versus placebo(12 weeks)