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

Primary Purpose

Hyperglycemia, Covid19

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Linagliptin tablet
Insulin
Sponsored by
Hospital Regional de Alta Especialidad del Bajio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Regional de Alta Especialidad del Bajìo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DPP4 inhibitor + insulin

Insulin scheme alone

Arm Description

Patients assigned to this group of treatment will receive Linagliptin 5mg orally once daily plus a basal-bolo insulin scheme

Patients assigned to this group will receive only a basal-bolus insulin scheme

Outcomes

Primary Outcome Measures

Glucose levels
Glucose levels during hospitalization
Number of patients who achieve metabolic control
Patients who achieve fasting glucose levels below 140 mg/dl and posprandial levels below 180 mg/dl

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2020
Last Updated
March 19, 2021
Sponsor
Hospital Regional de Alta Especialidad del Bajio
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1. Study Identification

Unique Protocol Identification Number
NCT04542213
Brief Title
Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19
Acronym
Covid19DPP4i
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Regional de Alta Especialidad del Bajio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The study will include two parallel groups of intervention
Masking
Care ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DPP4 inhibitor + insulin
Arm Type
Experimental
Arm Description
Patients assigned to this group of treatment will receive Linagliptin 5mg orally once daily plus a basal-bolo insulin scheme
Arm Title
Insulin scheme alone
Arm Type
Active Comparator
Arm Description
Patients assigned to this group will receive only a basal-bolus insulin scheme
Intervention Type
Drug
Intervention Name(s)
Linagliptin tablet
Other Intervention Name(s)
Linagliptin
Intervention Description
Linagliptin 5mg once daily plus a basal-bolus insulin scheme
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Insulin group
Intervention Description
Basal-bolus insulin scheme
Primary Outcome Measure Information:
Title
Glucose levels
Description
Glucose levels during hospitalization
Time Frame
5-10 days
Title
Number of patients who achieve metabolic control
Description
Patients who achieve fasting glucose levels below 140 mg/dl and posprandial levels below 180 mg/dl
Time Frame
5-10 days
Secondary Outcome Measure Information:
Title
Number of patients who die or need mechanical ventilation
Description
If the patient requires mechanical ventilation or dies
Time Frame
5-10 days
Title
C reactive protein levels
Description
C reactive protein measured at basal and at 5-10 days in mg/dl
Time Frame
5-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodolfo Guardado, PhD
Organizational Affiliation
Hospital Regional de Alta Especialidad del Bajìo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional de Alta Especialidad del Bajìo
City
Leòn
State/Province
Guanajuato
ZIP/Postal Code
37660
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19

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