The Efficacy of Mallya in Type 2 Diabetes Transiting From Oral Antidiabetic Drugs to iGlarLixi: a Randomized Controlled Trial Using Real-time Continuous Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time in range
研究概览
简要总结
This is a randomized, 12-week, open-label, active-controlled, parallel group study that will collect data of real-time continuous glucose monitoring for seven days at baseline and the end of study from adults with Type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs transiting to their first injectable therapy, iGlarLixi. A total of 40 patients will be recruited in Taipei Veterans General Hospital and randomized to use Mallya or receive standard care. The study is designed to demonstrate the efficacy of Mallya compared to standard care in terms of time in range (glucose level of 70-180 mg/dL), time above range (glucose level ≥180 mg/dL), time below range (glucose level <70 mg/dL), glycemic variability indices, changes in HbA1c and percentage of patients with HbA1c ≤7.0% at endpoint, time to stable dose, and diabetes treatment satisfaction. The result of the current study will provide insights into the utility of Mallya as a treatment monitoring solution to improve glycemic control.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥20 years-old
- •T2DM ≥ 180 days
- •HbA1c ≥ 7.0% at screening
- •Under stable doses of OADs for ≥12 weeks prior to screening
- •Insulin naïve (except short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes)
- •Not currently using real time continuous or flash glucose monitoring
- •Not currently using Mallya
排除标准
- •Known or suspected hypersensitivity to randomized treatment or related products
- •Previous participation in this study (Participation is defined as signed informed consent);
- •Participation (i.e., signed informed consent) in any interventional, clinical study within 90 days before screening (except for COVID-19 study);
- •Female who is pregnant, breast-feeding or intends to become pregnant
- •Presence of severe gastrointestinal disorders, such as severe gastroparesis;
- •Presence of severe renal dysfunction (eGFR <30 ml/min/1.73 m2) or end-stage renal disease on dialysis;
- •Presence of severe hepatic dysfunction (AST or ALT level ≥ 200 U/L);
- •Patients with a history of pancreatitis;
- •Patients receiving systemic corticosteroids
- •Patients with active cancer within the past six months.
结局指标
主要结局
Time in range
时间窗: 7 days of CGM data
The time in range (TIR) in percent (%) of a glucose level of 70-180 mg/dL obtained by real-time continuous glucose monitoring (rt-CGM) at the end of the study in both groups.
次要结局
- Mean of glucose levels(7 days of CGM data)
- Time above range (TAR)(7 days of CGM data)
- Coefficient of variation (CV) of glucose levels(7 days of CGM data)
- Treatment satisfaction questionnaire(12 weeks)
- Time below range (TBR)(7 days of CGM data)
- Standard deviation (SD) of glucose levels(7 days of CGM data)
- HbA1c(12 weeks)
- Time to stable dose(12 weeks)
研究者
vghtpe user
Attetnding Physician, Department of Endocrinology and Metabolism, Principal Investigator, Doctor of Philosophy, Associate Professor
Taipei Veterans General Hospital, Taiwan