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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04542213
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Rodolfo Guardado Mendoza, Hospital Regional de Alta Especialidad del Bajio

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
Hyperglycemia Covid19 Drug: Linagliptin tablet Drug: Insulin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The 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 : August 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

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 Name: 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 Name: Insulin group




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542213


Contacts
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Contact: Rodolfo Guardado, PhD 011-52-4772692000 guardamen@gmail.com

Locations
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Mexico
Hospital Regional de Alta Especialidad del Bajìo Recruiting
Leòn, Guanajuato, Mexico, 37660
Contact: Rodolfo Guardado, PhD    011-52-4772672000    guardamen@gmail.com   
Sub-Investigator: Liz Jovanna Martinez, MD         
Sub-Investigator: Miguel A Garcia, MD         
Sponsors and Collaborators
Hospital Regional de Alta Especialidad del Bajio
Investigators
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Principal Investigator: Rodolfo Guardado, PhD Hospital Regional de Alta Especialidad del Bajìo
  Study Documents (Full-Text)

Documents provided by Rodolfo Guardado Mendoza, Hospital Regional de Alta Especialidad del Bajio:
Publications:

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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: September 9, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing of the data can be done, depending on the requested purposes
Supporting Materials: Study Protocol
Time Frame: Data will be available once the main results of the study are published, and in accordance with the journal
Access Criteria: Direct contact with the principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action