A Double-Blind, Randomized, Active-Controlled Phase 2a Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TriGlytza®-01 in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16.
研究概览
简要总结
This Phase 2a, randomized, double-blind, active-controlled study will evaluate the safety, tolerability, and preliminary efficacy of TriGlytza®-01 compared with metformin in adults with Type 2 diabetes inadequately controlled despite metformin therapy. Participants will be randomized to one of three treatment groups and treated for 16 weeks. Safety, glycaemic control, body weight, and other metabolic outcomes will be assessed
详细描述
This is a multicentre, randomized, double-blind, active-controlled Phase 2a study evaluating TriGlytza®-01 in adults with Type 2 diabetes inadequately controlled on metformin therapy. Eligible participants will be randomized in a 1:1:1 ratio to metformin alone, low-dose TriGlytza®-01, or high-dose TriGlytza®-01. Treatment will continue for 16 weeks following screening. The study will evaluate safety, tolerability, glycaemic efficacy, body weight, pharmacokinetics, and selected metabolic biomarkers.
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
- •Adults aged 18 to 70 years. Confirmed diagnosis of Type 2 diabetes mellitus. Inadequate glycaemic control while receiving a stable dose of metformin.
- •Inclusion Criteria:
- •Adults aged 18 to 70 years.
- •Confirmed diagnosis of Type 2 diabetes mellitus.
- •Inadequate glycaemic control while receiving a stable dose of metformin.
- •HbA1c within the protocol-defined screening range.
- •Body mass index (BMI) 25 to 40 kg/m².
- •Adequate renal function.
- •Able and willing to provide written informed consent and comply with study procedures.
排除标准
- •Type 1 diabetes mellitus or history of diabetic ketoacidosis.
- •Use of prohibited glucose-lowering medications before screening.
- •Clinically significant renal, hepatic, gastrointestinal, cardiovascular, or other medical conditions that could interfere with study participation or safety.
- •Recent major cardiovascular event or unstable cardiovascular disease.
- •Previous bariatric surgery or recent treatment with anti-obesity medication.
- •Active infection or other uncontrolled medical condition.
- •Pregnant or breastfeeding, or unwilling to comply with protocol-required contraception.
- •Any condition that, in the investigator's opinion, would make participation unsuitable or compromise the study.
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16.
时间窗: 16 weeks
To demonstrate that after 24 weeks of treatment, the mean improved change in glycemic response from baseline, measured through mean reduction in HbA1c levels, for TriGlytza™ is superior to Metformin monotherapy.
时间窗: 24 weeks
Mean change in HbA1c from baseline to Treatment Week 24.
次要结局
- Change in HbA1c(16 weeks)
- Proportion achieving HbA1c <7.0%(16 weeks)
- Change in fasting plasma glucose(16 weeks)
- Change in body weight(16 weeks)
- Change from Baseline to Week 16 in Total Body Fat Percentage Measured by Dual-energy X-ray Absorptiometry (DEXA)(16 weeks)
- Requirement for rescue therapy(16 weeks)
- Maximum Plasma Concentration (Cmax) of Study Treatment Components(16 weeks)
- Time to Maximum Plasma Concentration (Tmax) of Study Treatment Components(16 weeks)
- Area Under the Plasma Concentration-Time Curve (AUC) of Study Treatment Components(16 weeks)
- Terminal Elimination Half-life (t½) of Study Treatment Components(16 Weeks)