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Effects of DPP4 Inhibition on COVID-19

Primary Purpose

Coronavirus Infection, Type 2 Diabetes

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Linagliptin
Insulin regimen
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring COVID-19, SARS-Cov 2, DPP4, Type 2 diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DPP4 group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in Glucose Llevels
Change in glucose control will be assessed via glucose levels obtained from blood serum samples

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2020
Last Updated
June 7, 2021
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT04341935
Brief Title
Effects of DPP4 Inhibition on COVID-19
Official Title
Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Logistical challenges amid COVID-19 pandemic and lack of financial support
Study Start Date
June 30, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Type 2 Diabetes
Keywords
COVID-19, SARS-Cov 2, DPP4, Type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DPP4 group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Other Intervention Name(s)
Tradjenta
Intervention Description
5 mg Linagliptin administered by mouth once daily
Intervention Type
Drug
Intervention Name(s)
Insulin regimen
Intervention Description
Standard of care insulin regimen as per hospital protocol
Primary Outcome Measure Information:
Title
Changes in Glucose Llevels
Description
Change in glucose control will be assessed via glucose levels obtained from blood serum samples
Time Frame
Baseline, up to 2 weeks
Secondary Outcome Measure Information:
Title
Changes in SpO2 levels
Description
changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method
Time Frame
Baseline, up to 2 weeks
Title
Changes in Interleukin 6 (IL6)
Description
Changes in IL 6 will be assessed from blood serum samples
Time Frame
Baseline, up to 2 weeks
Title
Changes in chest structures
Description
Changes in Chest radiography (X-ray)
Time Frame
Baseline, up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianluca Iacobellis, MD PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32178593
Citation
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.
Results Reference
result
PubMed Identifier
32224164
Citation
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.
Results Reference
result

Learn more about this trial

Effects of DPP4 Inhibition on COVID-19

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