Covid19, Hyperglycemia
Conditions
Brief summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been a world health issue during the last months, affecting mostly countries with a high metabolic risk, like Mexico. Patients with type 2 diabetes (T2D) have an increased risk of any kind of infection as well as an increased mortality risk. Hyperglycemia has been established as an important predictor of mortality in patients with T2D and SARS-CoV-2. The standard treatment of hyperglycemia in hospitalized patients has been basen on insulin schemes, but recently evidence suggest the utility of some other drugs, reducing the risk of hypoglucemia and increasing the probability of a proper metabolic control. The goal of this study is to compare the utility of dipeptidyl peptidase-4 inhibitor (DPP4i) as a combination with insulin on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 and hyperglycemia.
Detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been a world health issue during the last months, affecting mostly countries with a high metabolic risk, like Mexico. Patients with type 2 diabetes (T2D) have an increased risk of any kind of infection as well as an increased mortality risk. Hyperglycemia has been established as an important predictor of mortality in patients with T2D and SARS-CoV-2. The standard treatment of hyperglycemia in hospitalized patients has been basen on insulin schemes, but recently evidence suggest the utility of some other drugs, reducing the risk of hypoglucemia and increasing the probability of a proper metabolic control. DPP4 enzyme has an ubiquitous distribution and has been considered as a pro-inflammatory enzyme, considering that DPP4 inhibitors could have and anti-inflammatory effect, as it has been shown in different works. The goal os this study is to compare the utility of DPP4 inhibitor as a combination with insulin on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 and hyperglycemia. For this purpose we will randomize patients with SARS-CoV-2 and hyperglycemia to receive either the combination of DPP4i + insulin or insulin alone and will follow al algorithm treatment to define metabolic control as well as prognosis.
Interventions
Linagliptin 5mg once daily plus a basal-bolus insulin scheme
DRUGInsulin
Basal-bolus insulin scheme
Sponsors
Hospital Regional de Alta Especialidad del Bajio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Physicians who will be providing health support will not be aware of the treatment that patients will be receiving regarding this protocol, also the principal investigator and the personal who will be measuring glucose levels and prognosis, will not be aware of the group of treatment, since all the patients will be receiving the same protocol of insulin administration
Intervention model description
The study will include two parallel groups of intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients with confirmed infection by SARS-CoV-2 * Hyperglycemia higher than 140 mg/dl * Patients accepting oral medications * Both sex * Older than 18 years of age * Patients who accept to participate in the study and sign the consent form
Exclusion criteria
* Type 1 diabetes * Pregnancy * Hyperosmolar hyperglycemic state or diabetic ketoacidosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose levels | 5-10 days | Glucose levels during hospitalization |
| Number of patients who achieve metabolic control | 5-10 days | Patients who achieve fasting glucose levels below 140 mg/dl and posprandial levels below 180 mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who die or need mechanical ventilation | 5-10 days | If the patient requires mechanical ventilation or dies |
| C reactive protein levels | 5-10 days | C reactive protein measured at basal and at 5-10 days in mg/dl |
Countries
Mexico
Outcome results
None listed