Clinical trial NCT04542213: Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperglycemia
Covid19
Lead sponsor: Hospital Regional de Alta Especialidad del Bajio
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will include two parallel groups of intervention
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glucose levels
timeFrame: 5-10 days
measure: Number of patients who achieve metabolic control
timeFrame: 5-10 days
Secondary outcomes:
measure: Number of patients who die or need mechanical ventilation
timeFrame: 5-10 days
measure: C reactive protein levels
timeFrame: 5-10 days
Other outcomes:
Locations:
city: Leòn
country: Mexico
facility: Hospital Regional de Alta Especialidad del Bajìo
state: Guanajuato
Study officials:
affiliation: Hospital Regional de Alta Especialidad del Bajìo
name: Rodolfo Guardado, PhD
role: PRINCIPAL_INVESTIGATOR
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