Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of the Combination of Dipeptidyl Peptidase-4 Inhibitor (DPP4i) and Insulin in Comparison to Insulin on Metabolic Control and Prognosis in Hospitalized Patients With COVID-19

Conditions
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Hyperglycemia, Covid19

Intervention / Treatment
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* Drug: Linagliptin tablet
* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will include two parallel groups of intervention
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DPP4 inhibitor + insulin<br>Patients assigned to this group of treatment will receive Linagliptin 5mg orally once daily plus a basal-bolo insulin scheme | Drug: Linagliptin tablet<br>* Linagliptin 5mg once daily plus a basal-bolus insulin scheme<br>* Other names: Linagliptin;|
| Active Comparator: Insulin scheme alone<br>Patients assigned to this group will receive only a basal-bolus insulin scheme | Drug: Insulin<br>* Basal-bolus insulin scheme<br>* Other names: Insulin group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose levels | Glucose levels during hospitalization | 5-10 days | 
| Number of patients who achieve metabolic control | Patients who achieve fasting glucose levels below 140 mg/dl and posprandial levels below 180 mg/dl | 5-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who die or need mechanical ventilation | If the patient requires mechanical ventilation or dies | 5-10 days | 
| C reactive protein levels | C reactive protein measured at basal and at 5-10 days in mg/dl | 5-10 days |