Effects of DPP4 Inhibition on COVID-19

Sponsor

University of Miami (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04341935

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection Type 2 Diabetes	Drug: Linagliptin Drug: Insulin regimen	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes

Anticipated Study Start Date :

Jun 30, 2021

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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