Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-05-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of DPP4 Inhibition on COVID-19

NCT04341935

Coronavirus Infection Type 2 Diabetes

WITHDRAWN PHASE4

Antidiabetic Effects of Adding a DPP-4 Inhibitor to Pre-Existing Treatment With an Incretin Mimetic in Patients With T2D

NCT01937598

Type 2 Diabetes

COMPLETED PHASE3

DPP4inhibitors in Type 1 Diabetes

NCT01922817

Type 1 Diabetes Hypoglycaemia

COMPLETED PHASE3

The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients

NCT04365517

Covid19 Diabetes Mellitus, Type 2 CKD

UNKNOWN PHASE3

Efficacy and Safety Study of SHR117887 in Combination With Metformin in Patients With Type 2 Diabetes

NCT01984489

Type 2 Diabetes

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID 19 Coronavirus Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases Dipeptidyl-Peptidase IV Inhibitors Linagliptin Severe Acute Respiratory Syndrome Coronavirus 2 Sars-CoV2 Hypoglycemic Agents Respiratory Tract Diseases Incretins Hormones

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DPP-4 inhibition

Participants in the Dipeptidyl Peptidase-4 (DPP-4) inhibition group will receive linagliptin in addition to standard of care insulin regimen as per hospital protocol during their entire hospitalization.

Group Type EXPERIMENTAL

Linagliptin 5 MG

Intervention Type DRUG

Linagliptin 5 mg PO once daily

Control

Participants in the control group will receive only the standard of care insulin regimen as per hospital protocol during their entire hospitalization.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Linagliptin 5 MG

Linagliptin 5 mg PO once daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Trajenta

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 18 years.
2. History of or type 2 diabetes mellitus or a diagnosis of type 2 diabetes during hospitalization.
3. Confirmation of infection with SARS-CoV-2 by PCR testing.
4. Patients within 10 days from symptom onset or patients within 48 hours after laboratory diagnosis (SARS-CoV-2 PCR).

Exclusion Criteria

1. WHO COVID-19 Ordinal Scale for Clinical Improvement ≥ 6.
2. Respiratory failure requiring mechanical ventilation prior to randomization.
3. Use of vasopressor or inotropic medications prior to randomization.
4. Intolerance/hypersensitivity to dipeptidyl peptidase-4 inhibitors.
5. Patients expected to require intensive care unit admission or immediate surgical intervention.
6. Participation in another trial assessing any treatment for COVID-19.
7. Current treatment with a DPP-4 inhibitor.
8. Pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No