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

Covid19 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542213
• Other study ID #: CEI-22-2020
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: Hospital Regional de Alta Especialidad del Bajio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Hyperglycemia

Intervention

Drug:
• Linagliptin tablet
Linagliptin 5mg once daily plus a basal-bolus insulin scheme
• Insulin
Basal-bolus insulin scheme

Locations

Country	Name	City	State
Mexico	Hospital Regional de Alta Especialidad del Bajìo	Leòn	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Regional de Alta Especialidad del Bajio

Country where clinical trial is conducted

Mexico, 

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* Note: There are 63 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose levels	Glucose levels during hospitalization	5-10 days
Primary	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	Number of patients who die or need mechanical ventilation	If the patient requires mechanical ventilation or dies	5-10 days
Secondary	C reactive protein levels	C reactive protein measured at basal and at 5-10 days in mg/dl	5-10 days