Effects of DPP4 Inhibition on COVID-19

NCT04341935 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 20200384
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Coronavirus Infection; Type 2 Diabetes

Keywords

COVID-19; SARS-Cov 2; DPP4; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in SpO2 levels

  Baseline, up to 2 weeks

• Changes in Interleukin 6 (IL6)

  Baseline, up to 2 weeks

• Changes in chest structures

  Baseline, up to 2 weeks

Study Arms (2)

DPP4 group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Linagliptin DRUG

5 mg Linagliptin administered by mouth once daily

Also known as: Tradjenta

DPP4 group

Insulin regimen DRUG

Standard of care insulin regimen as per hospital protocol

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (2)

• 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.

  PMID: 32178593 RESULT

• 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.

  PMID: 32224164 RESULT

MeSH Terms

Conditions

Coronavirus Infections; Diabetes Mellitus, Type 2; COVID-19

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Officials

• Gianluca Iacobellis, MD PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 10, 2020
• Study Start: June 30, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)