Effects of DPP4 Inhibition on COVID-19

Study Overview
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Brief Summary
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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

Official Title
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Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes

Conditions
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Coronavirus Infection, Type 2 Diabetes

Intervention / Treatment
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* Drug: Linagliptin
* Drug: Insulin regimen


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DPP4 group<br>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 | Drug: Linagliptin<br>* 5 mg Linagliptin administered by mouth once daily<br>* Other names: Tradjenta;|
| Active Comparator: Control group<br>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 | Drug: Insulin regimen<br>* Standard of care insulin regimen as per hospital protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Glucose Llevels | Change in glucose control will be assessed via glucose levels obtained from blood serum samples | Baseline, up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in SpO2 levels | changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method | Baseline, up to 2 weeks | 
| Changes in Interleukin 6 (IL6) | Changes in IL 6 will be assessed from blood serum samples | Baseline, up to 2 weeks | 
| Changes in chest structures | Changes in Chest radiography (X-ray) | Baseline, up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-Cov 2, DPP4, Type 2 diabetes