Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19 (Covid19DPP4i)

March 19, 2021 updated by: Rodolfo Guardado Mendoza, Hospital Regional de Alta Especialidad del Bajio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • Leòn, Guanajuato, Mexico, 37660
        • Hospital Regional de Alta Especialidad del Bajio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose levels
Time Frame: 5-10 days
Glucose levels during hospitalization
5-10 days
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
5-10 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Regional de Alta Especialidad del Bajio

Investigators

  • Principal Investigator: Rodolfo Guardado, PhD, Hospital Regional de Alta Especialidad del Bajio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-22-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing of the data can be done, depending on the requested purposes

IPD Sharing Time Frame

Data will be available once the main results of the study are published, and in accordance with the journal

IPD Sharing Access Criteria

Direct contact with the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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