Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in Glucose Llevels
研究概览
简要总结
The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus (T2DM) as per American Diabetes Association (ADA) guidelines
- •Confirmed COVID-19
- •Mild COVID-19 defined as any of the following: fever, malaise, cough, headache, sore throat, myalgia, nasal congestion, diarrhea
- •Moderate COVID-19 is defined as > 2 of the following in non-intubated patients: any symptom of mild disease, radiographic imaging (chest x-ray or lung ultrasound) with bilateral ground glass opacities or bilateral consolidations, SpO2 <90% up to 5L Nasal Cannula (NC)
- •No additional signs or symptoms of severe COVID-19.
排除标准
- •Type 1 Diabetes Mellitus (T1DM) diabetes, as per ADA guidelines
- •History of Diabetic Ketoacidosis (DKA)
- •History of acute pancreatitis
- •Chronic or Acute Renal Failure with Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2
- •Exclusion Criteria:
- •T1DM diabetes, as per ADA guidelines, History of DKA, History of acute pancreatitis; Chronic or Acute Renal Failure with eGFR < 30 ml/min/1.73 m2
研究组 & 干预措施
DPP4 group
Participants in the Dipeptidyl Peptidase 4 (DPP4) group will receive Linagliptin in addition to standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days
干预措施: Linagliptin (Drug)
Control group
Participants in the control group will receive only the standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days
干预措施: Insulin regimen (Drug)
结局指标
主要结局
Changes in Glucose Llevels
时间窗: Baseline, up to 2 weeks
Change in glucose control will be assessed via glucose levels obtained from blood serum samples
次要结局
- Changes in SpO2 levels(Baseline, up to 2 weeks)
- Changes in Interleukin 6 (IL6)(Baseline, up to 2 weeks)
- Changes in chest structures(Baseline, up to 2 weeks)
研究者
Gianluca Iacobellis
Professor of Medicine
University of Miami