Official Title
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
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.

Completed
Hyperglycemia
COVID19

Drug: Linagliptin tablet

Linagliptin 5mg once daily plus a basal-bolus insulin scheme
Other Name: Linagliptin

Drug: Insulin

Basal-bolus insulin scheme
Other Name: Insulin group

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Mexico
Locations

Hospital Regional de Alta Especialidad del Bajìo
Leòn, Guanajuato, Mexico

Rodolfo Guardado, PhD, Principal Investigator
Hospital Regional de Alta Especialidad del Bajìo

Hospital Regional de Alta Especialidad del Bajio
NCT Number
MeSH Terms
COVID-19
Hyperglycemia
Insulin
Insulin, Globin Zinc
Linagliptin