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

Coronavirus Infection
Type 2 Diabetes

Drug: Linagliptin

5 mg Linagliptin administered by mouth once daily
Other Name: Tradjenta

Drug: Insulin regimen

Standard of care insulin regimen as per hospital protocol

Eligibility Criteria

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United States

University of Miami
Miami, Florida, United States

Gianluca Iacobellis, MD PhD, Principal Investigator
University of Miami

University of Miami
NCT Number
Type 2 diabetes
MeSH Terms
Coronavirus Infections
Diabetes Mellitus, Type 2