Effects of DPP4 Inhibition on COVID-19

Phase 4

Withdrawn

• Conditions: Coronavirus Infection; Type 2 Diabetes
• Interventions: Drug: Insulin regimen; Drug: Linagliptin

• Registration Number: NCT04341935
• Lead Sponsor: University of Miami

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-10
• Study Start: 2021-06-30
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Insulin regimen	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
DPP4 group	Linagliptin	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

Primary Outcome Measures

Name	Time	Method
Changes in Glucose Llevels	Baseline, up to 2 weeks	Change in glucose control will be assessed via glucose levels obtained from blood serum samples

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States