Coronavirus Infection, Type 2 Diabetes
Conditions
Keywords
COVID-19, SARS-Cov 2, DPP4, Type 2 diabetes
Brief summary
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
Interventions
5 mg Linagliptin administered by mouth once daily
Standard of care insulin regimen as per hospital protocol
Sponsors
Study design
Eligibility
Inclusion criteria
* Type 2 Diabetes Mellitus (T2DM) as per American Diabetes Association (ADA) guidelines * Age ≥ 18 * 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Glucose Llevels | Baseline, up to 2 weeks | Change in glucose control will be assessed via glucose levels obtained from blood serum samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in SpO2 levels | Baseline, up to 2 weeks | changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method |
| Changes in Interleukin 6 (IL6) | Baseline, up to 2 weeks | Changes in IL 6 will be assessed from blood serum samples |
| Changes in chest structures | Baseline, up to 2 weeks | Changes in Chest radiography (X-ray) |
Countries
United States