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

NCT04542213 | Completed Phase 3 DMC

• 1 other identifier: CEI-22-2020
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Covid19

Outcome Measures

Primary Outcomes (2)

• Glucose levels

  Glucose levels during hospitalization

  5-10 days

• Number of patients who achieve metabolic control

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

  5-10 days

Secondary Outcomes (2)

• Number of patients who die or need mechanical ventilation

  5-10 days

• C reactive protein levels

  5-10 days

Study Arms (2)

DPP4 inhibitor + insulin

EXPERIMENTAL

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

Drug: Linagliptin tablet

Insulin scheme alone

ACTIVE COMPARATOR

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

Drug: Insulin

Interventions

Linagliptin tablet DRUG

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

Also known as: Linagliptin

DPP4 inhibitor + insulin

Insulin DRUG

Basal-bolus insulin scheme

Also known as: Insulin group

Insulin scheme alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Type 1 diabetes
• Pregnancy
• Hyperosmolar hyperglycemic state or diabetic ketoacidosis

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad del Bajio: lead

Study Sites (1)

Hospital Regional de Alta Especialidad del Bajìo

Leòn, Guanajuato, 37660, Mexico

Location

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• Pasquel FJ, Gianchandani R, Rubin DJ, Dungan KM, Anzola I, Gomez PC, Peng L, Hodish I, Bodnar T, Wesorick D, Balakrishnan V, Osei K, Umpierrez GE. Efficacy of sitagliptin for the hospital management of general medicine and surgery patients with type 2 diabetes (Sita-Hospital): a multicentre, prospective, open-label, non-inferiority randomised trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):125-133. doi: 10.1016/S2213-8587(16)30402-8. Epub 2016 Dec 8.

  PMID: 27964837 BACKGROUND

• Umpierrez GE, Gianchandani R, Smiley D, Jacobs S, Wesorick DH, Newton C, Farrokhi F, Peng L, Reyes D, Lathkar-Pradhan S, Pasquel F. Safety and efficacy of sitagliptin therapy for the inpatient management of general medicine and surgery patients with type 2 diabetes: a pilot, randomized, controlled study. Diabetes Care. 2013 Nov;36(11):3430-5. doi: 10.2337/dc13-0277. Epub 2013 Jul 22.

  PMID: 23877988 BACKGROUND

• Guardado-Mendoza R, Garcia-Magana MA, Martinez-Navarro LJ, Macias-Cervantes HE, Aguilar-Guerrero R, Suarez-Perez EL, Aguilar-Garcia A. Effect of linagliptin plus insulin in comparison to insulin alone on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 infection. Sci Rep. 2022 Jan 11;12(1):536. doi: 10.1038/s41598-021-04511-1.

  PMID: 35017617 DERIVED

MeSH Terms

Conditions

Hyperglycemia; COVID-19

Interventions

Linagliptin; Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rodolfo Guardado, PhD

  Hospital Regional de Alta Especialidad del Bajìo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will include two parallel groups of intervention

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 9, 2020
• Study Start: August 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

ME (1)