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

Sponsor
Hospital Regional de Alta Especialidad del Bajio (Other)
Overall Status
Completed
CT.gov ID
NCT04542213
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study will include two parallel groups of interventionThe study will include two parallel groups of intervention
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Physicians who will be providing health support will not be aware of the treatment that patients will be receiving regarding this protocol, also the principal investigator and the personal who will be measuring glucose levels and prognosis, will not be aware of the group of treatment, since all the patients will be receiving the same protocol of insulin administration
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Feb 28, 2021
Actual Study Completion Date :
Feb 28, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glucose levels [5-10 days]

      Glucose levels during hospitalization

    2. 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

    Secondary Outcome Measures

    1. Number of patients who die or need mechanical ventilation [5-10 days]

      If the patient requires mechanical ventilation or dies

    2. C reactive protein levels [5-10 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Regional de Alta Especialidad del Bajìo Leòn Guanajuato Mexico 37660

    Sponsors and Collaborators

    • Hospital Regional de Alta Especialidad del Bajio

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Rodolfo Guardado Mendoza, Principal Investigator, Hospital Regional de Alta Especialidad del Bajio
    ClinicalTrials.gov Identifier:
    NCT04542213
    Other Study ID Numbers:
    • CEI-22-2020
    First Posted:
    Sep 9, 2020
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Hyperglycemia
    Insulin
    Insulin, Globin Zinc
    Linagliptin

    Study Results

    No Results Posted as of Mar 23, 2021