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Completed

NCT Number: NCT04542213

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

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.

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Key information

Conditions

Hyperglycemia COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Glucose Metabolism Disorders Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Regional de Alta Especialidad del Bajìo

Leòn, Guanajuato, 37660, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linagliptin tablet

Drug

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

Other names: Linagliptin

Insulin

Drug

Basal-bolus insulin scheme

Other names: Insulin group

Primary outcomes

  1. Glucose levels

    Time frame: 5-10 days

    Glucose levels during hospitalization

  2. Number of patients who achieve metabolic control

    Time frame: 5-10 days

    Patients who achieve fasting glucose levels below 140 mg/dl and posprandial levels below 180 mg/dl

Secondary outcomes

  1. Number of patients who die or need mechanical ventilation

    Time frame: 5-10 days

    If the patient requires mechanical ventilation or dies

  2. C reactive protein levels

    Time frame: 5-10 days

    C reactive protein measured at basal and at 5-10 days in mg/dl

Sponsors and collaborators

Lead sponsor

Hospital Regional de Alta Especialidad del Bajio

Other

Registry information

Official study 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

Acronym: Covid19DPP4i

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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