Status:
UNKNOWN
The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients
Lead Sponsor:
University of Milan
Conditions:
Covid19
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The COVID-19 pathology is frequently associated with diabetes mellitus and metabolic syndrome. In the epidemic outbreak that exploded at the beginning of 2020 in the Lombardy Region, about two thirds ...
Detailed Description
The investigators propose a randomized controlled open label intervention study. Patients hospitalized for COVID-19 and affected by type 2 diabetes mellitus will be included in the study and divided i...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes, according to ADA 2020 criteria
- HbA1c levels at the entrance or in the two previous months \<9%
- Diagnosis of Covid-19 (swab for positive SARS-COV2 RNA) with pneumonia, with or without increase in inflammation indexes, with or without respiratory failure
- No indication for tocilizumab therapy (BCRSS, Brescia Covid Respiratory Severity Scale, \<3).
- Written and dated informed consent from the patient or his legally valid representative
Exclusion
- Pregnancy
- Type 1 diabetes
- Stage IV and V renal failure (stimated glomerular filtration rate \<30 ml / min)
- Treatment with Dipeptidyl peptidase-4 inhibitors or GLP-1 Receptor Agonists in the month prior to hospitalization
- Pioglitazone treatment in the month prior to hospitalization
- Treatment in the month preceding or in the course of hospitalization with "biological" drugs for immuno-rheumatological diseases (in particular tocilizumab)
- Presence of other acute or chronic ongoing infections
- Neurological or psychiatric diseases, diagnosis of hemoglobinopathy, diagnosis of liver disease, cancer, cystic fibrosis or malabsorption syndrome
- Dysphagia with need for artificial nutrition
- Positive history of acute and chronic pancreatitis
- Unstable cardiovascular disease or known atherosclerotic disease
- A history of alcohol or drug abuse
- Known human immunodeficiency virus (HIV) or hepatitis
- Presence of serious diseases or conditions that make the patient unsuitable for the study
- Surgery in the previous two weeks
Key Trial Info
Start Date :
December 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04365517
Start Date
December 29 2021
End Date
December 30 2022
Last Update
September 28 2021
Active Locations (1)
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1
ASST FBF Sacco
Milan, Italy, 20157