Sitagliptin Treatment in Diabetic COVID-19 Positive Patients (SIDIACO-RETRO')
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ClinicalTrials.gov Identifier: NCT04382794 |
Recruitment Status :
Completed
First Posted : May 11, 2020
Last Update Posted : July 9, 2020
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Condition or disease | Intervention/treatment |
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Covid19 | Drug: Retrospective case-control analysis |
An observational, retrospective-case control, multi-center study is proposed to evaluate any effects of Sitagliptin on clinical, laboratory and instrumental parameters in the course of hospitalization for COVID-19. The data will be extracted anonymously from the computerized medical records commonly used in clinical practice by the centers involved in the study. The evaluation will be performed by comparing the parameters of COVID-19 positive diabetic patients treated with Sitagliptin with those of a group of COVID-19 positive diabetic patients not treated with Sitagliptin. All diabetic subjects treated with Sitagliptin (100 mg / day, 50 mg / day or 25 mg / day) and all diabetic subjects not treated with Sitagliptin, eligible for inclusion / exclusion criteria, will be included in the analysis.
The clinical data of patients that will be collected anonymously during hospitalization will include: smoking habit, remote medical history aimed at assessing the presence of comorbidities (atrial fibrillation, heart failure, hypertension, arterial hypertension, chronic obstructive pulmonary disease, other lung disease, chronic renal failure, decay cognitive, Parkinson's disease, autoimmune diseases), pharmacological history (treatment introduced during hospitalization for COVID-19, respiratory failure or other complications; use of ACE-inhibitors, sartans, calcium channel blockers, diuretics, antiarrhythmics, beta blockers, anti-aggregants, anticoagulants, neuroleptics ). Anthropometric parameters including blood pressure measurement and BMI will also be collected.
For all patients, the following data will be collected at the baseline (first data available upon entry into the hospitalization regime) and upon discharge:
- Clinical picture and symptoms (presence of cough, body temperature, respiratory rate, need for ventilatory support, duration of ventilatory support in days, duration of oxygen therapy in day, duration of hospitalization in Intensive Care Unit in days, total length of stay in days, blood gas parameters, PaO2 / FiO2 ratio, oxygen saturation by pulse oximeter)
- Routine blood chemistry tests performed in hospitalization (e.g. glycemia, reactive protein C, blood count with formula, erythrocyte sedimentation rate, blood gas analysis, LDH, inflammation indices).
- Instrumental exams (chest x-ray)
- glycated hemoglobin
- Serum creatinine and Estimated Glomerular Filtration Rate (estimated with CKD-EPI)
- Presence of specific comorbidities for diabetes
- Average daily blood sugar levels (from capillary blood)
Study Type : | Observational |
Actual Enrollment : | 338 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Sitagliptin Treatment in Diabetic COVID-19 Positive Patients: Retrospective Study |
Actual Study Start Date : | May 14, 2020 |
Actual Primary Completion Date : | June 15, 2020 |
Actual Study Completion Date : | June 15, 2020 |

Group/Cohort | Intervention/treatment |
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DMT2 COVID19 positive patients treated with Sitagliptin
The anonymous data relating to the clinical, laboratory and instrumental parameters of patients hospitalized for COVID-19 and suffering from type 2 diabetes treated with Sitagliptin will be extracted from the medical records currently in use in the centers participating in the study. The data will be anonymous and not attributable to individual subjects
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Drug: Retrospective case-control analysis
Evaluation of clinical, laboratory and instrumental parameters of diabetic patients during hospitalization for COVID-19. The data will be extracted anonymously from the computerized medical records commonly used in clinical practice by the centers involved in the study |
DMT2 COVID19 positive patients not treated with Sitagliptin
The anonymous data relating to the clinical, laboratory and instrumental parameters of patients hospitalized for COVID-19 and suffering from type 2 diabetes not treated with Sitagliptin will be extracted from the medical records currently in use in the centers participating in the study. The data will be anonymous and not attributable to individual subjects
|
Drug: Retrospective case-control analysis
Evaluation of clinical, laboratory and instrumental parameters of diabetic patients during hospitalization for COVID-19. The data will be extracted anonymously from the computerized medical records commonly used in clinical practice by the centers involved in the study |
- Clinical parameter of acute lung disease [ Time Frame: 1 month ]Clinical evaluation of physiological parameter "cough" associated with acute lung disease from the beginning of the study to the end of the study
- Clinical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the clinical parameter "oxygen saturation by the use of a pulse oximeter" of acute lung disease from the beginning of the study to the end of the study
- Clinical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the clinical parameter "body temperature" of acute lung disease from the beginning of the study to the end of the study
- Clinical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the clinical parameter "PaO2/FiO2" of acute lung disease from the beginning of the study to the end of the study
- Clinical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the clinical parameter "respiratory rate" of acute lung disease from the beginning of the study to the end of the study
- Clinical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the clinical parameter "need for ventilator support" of acute lung disease from the beginning of the study to the end of the study
- Clinical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the clinical parameter "duration in days of ventilator support, duration in days of oxygen therapy, duration in days of hospitalization, duration in days in the Intensive Care Unit, total length of stay in hospital" of acute lung disease from the beginning of the study to the end of the study
- Death [ Time Frame: 1 month ]Death of the patient during hospitalization due to COVID19
- Biochemical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the biochemical parameter "reactive C protein" of acute lung disease from the beginning of the study to the end of the study
- Biochemical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the biochemical parameter "blood count with formula" of acute lung disease from the beginning of the study to the end of the study
- Biochemical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the biochemical parameter "erythrocyte sedimentation rate" of acute lung disease from the beginning of the study to the end of the study
- Biochemical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the biochemical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of the study
- Biochemical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the biochemical parameter "LDH" of acute lung disease from the beginning of the study to the end of the study
- Biochemical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the biochemical parameter "fasting blood glucose" of acute lung disease from the beginning of the study to the end of the study
- Clinical parameter of acute lung disease [ Time Frame: 1 month ]Variation of the clinical parameter "chest X ray" of acute lung disease from the beginning of the study to the end of the study

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Diagnosis of type 2 diabetes, according to ADA 2020 criteria
- Diagnosis of COVID-19 (positive SARS-COV2 RNA buffer) with pneumonia, with or without an increase in inflammation indexes, with or without respiratory failure
Exclusion Criteria:
- Pregnancy
- Type 1 diabetes
- Presence of other acute infections in place
- Presence of serious diseases or conditions that make the patient unsuitable for the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382794
Italy | |
ASST FBF-Sacco P.O. Sacco | |
Milan, MI, Italy, 20157 | |
Papa Giovanni XXIII Hospital | |
Bergamo, Italy, 24127 | |
Ospedale dell'Angelo, Venezia-Mestre | |
Mestre, Italy, 30174 | |
Humanitas Hospital | |
Milan, Italy, 20089 | |
University of Pavia | |
Pavia, Italy, 20100 | |
IRCCS Policlinico S. Matteo | |
Pavia, Italy, 27100 |
Principal Investigator: | Paolo Fiorina, MD, PhD | ASST FBF Sacco |
Responsible Party: | Paolo Fiorina, MD, Clinical Professor, University of Milan |
ClinicalTrials.gov Identifier: | NCT04382794 |
Other Study ID Numbers: |
5/2020 |
First Posted: | May 11, 2020 Key Record Dates |
Last Update Posted: | July 9, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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.: | Yes |
Covid19 Sitagliptin Diabetes Mellitus, Type 2 |