Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2021-06-30
2021-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
NCT04371978
Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.
NCT07019012
The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin
NCT03458715
The Effect of Linagliptin on Mitochondrial and Endothelial Function
NCT01969084
DPP4inhibitors in Type 1 Diabetes
NCT01922817
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Linagliptin
5 mg Linagliptin administered by mouth once daily
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
Insulin regimen
Standard of care insulin regimen as per hospital protocol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Linagliptin
5 mg Linagliptin administered by mouth once daily
Insulin regimen
Standard of care insulin regimen as per hospital protocol
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Miami
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gianluca Iacobellis
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gianluca Iacobellis, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20200384
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.