Effects of DPP4 Inhibition on COVID-19

Purpose

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

Conditions

  • Coronavirus Infection
  • Type 2 Diabetes

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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
  • Drug: Linagliptin
    5 mg Linagliptin administered by mouth once daily
    Other names:
    • Tradjenta
Active Comparator
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
  • Drug: Insulin regimen
    Standard of care insulin regimen as per hospital protocol

Recruiting Locations

More Details

NCT ID
NCT04341935
Status
Withdrawn
Sponsor
University of Miami