Effects of DPP4 Inhibition on COVID-19

University of Miami

Status and phase: Withdrawn; Phase 4

Conditions: Type 2 Diabetes; Coronavirus Infection

Treatments: Drug: Insulin regimen; Drug: Linagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT04341935

20200384

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

DPP4 group

Experimental group

Description:

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

Treatment:

Drug: Linagliptin

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Insulin regimen