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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

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Withdrawn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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.