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Effects of DPP4 Inhibition on COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341935
Recruitment Status : Withdrawn (Logistical challenges amid COVID-19 pandemic and lack of financial support)
First Posted : April 10, 2020
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Gianluca Iacobellis, University of Miami

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : June 30, 2021
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Changes in Glucose Llevels [ Time Frame: Baseline, up to 2 weeks ]
    Change in glucose control will be assessed via glucose levels obtained from blood serum samples


Secondary Outcome Measures :
  1. Changes in SpO2 levels [ Time Frame: Baseline, up to 2 weeks ]
    changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method

  2. Changes in Interleukin 6 (IL6) [ Time Frame: Baseline, up to 2 weeks ]
    Changes in IL 6 will be assessed from blood serum samples

  3. Changes in chest structures [ Time Frame: Baseline, up to 2 weeks ]
    Changes in Chest radiography (X-ray)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341935


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Gianluca Iacobellis, MD PhD University of Miami
More Information
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Publications of Results:

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Responsible Party: Gianluca Iacobellis, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT04341935    
Other Study ID Numbers: 20200384
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Gianluca Iacobellis, University of Miami:
COVID-19
SARS-Cov 2
DPP4
Type 2 diabetes
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action