Skip to content

Effects of DPP4 Inhibition on COVID-19

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04341935
Enrollment
0
Registered
2020-04-10
Start date
2021-06-30
Completion date
2021-12-30
Last updated
2021-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection, Type 2 Diabetes

Keywords

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

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

Interventions

DRUGLinagliptin

5 mg Linagliptin administered by mouth once daily

DRUGInsulin regimen

Standard of care insulin regimen as per hospital protocol

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Glucose LlevelsBaseline, up to 2 weeksChange in glucose control will be assessed via glucose levels obtained from blood serum samples

Secondary

MeasureTime frameDescription
Changes in SpO2 levelsBaseline, up to 2 weekschanges in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method
Changes in Interleukin 6 (IL6)Baseline, up to 2 weeksChanges in IL 6 will be assessed from blood serum samples
Changes in chest structuresBaseline, up to 2 weeksChanges in Chest radiography (X-ray)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026