Effects of DPP4 Inhibition on COVID-19

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

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

Study Overview

• Status: Withdrawn
• Conditions: Coronavirus Infection; Type 2 Diabetes
• Intervention / Treatment: Drug: Linagliptin; Drug: Insulin regimen

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami

Publications and helpful links

General Publications

• Vankadari N, Wilce JA. Emerging WuHan (COVID-19) coronavirus: glycan shield and structure prediction of spike glycoprotein and its interaction with human CD26. Emerg Microbes Infect. 2020 Mar 17;9(1):601-604. doi: 10.1080/22221751.2020.1739565. eCollection 2020.
• Iacobellis G. COVID-19 and diabetes: Can DPP4 inhibition play a role? Diabetes Res Clin Pract. 2020 Apr;162:108125. doi: 10.1016/j.diabres.2020.108125. Epub 2020 Mar 26. No abstract available.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 30, 2021
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (ACTUAL): April 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Type 2 diabetes; COVID-19; SARS-Cov 2; DPP4
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; Diabetes Mellitus; COVID-19; Coronavirus Infections; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Linagliptin
• Other Study ID Numbers: 20200384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No