Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19
- Registration Number
- NCT04542213
- Lead Sponsor
- Hospital Regional de Alta Especialidad del Bajio
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- Type 1 diabetes
- Pregnancy
- Hyperosmolar hyperglycemic state or diabetic ketoacidosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DPP4 inhibitor + insulin Linagliptin tablet Patients assigned to this group of treatment will receive Linagliptin 5mg orally once daily plus a basal-bolo insulin scheme Insulin scheme alone Insulin Patients assigned to this group will receive only a basal-bolus insulin scheme
- Primary Outcome Measures
Name Time Method 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
Glucose levels 5-10 days Glucose levels during hospitalization
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hospital Regional de Alta Especialidad del Bajìo
🇲🇽Leòn, Guanajuato, Mexico