Effects of DPP4 Inhibition on COVID-19

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04341935
• Other study ID #: 20200384
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 30, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Linagliptin
5 mg Linagliptin administered by mouth once daily
• Insulin regimen
Standard of care insulin regimen as per hospital protocol

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. eCollectio — View Citation

Outcome

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