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Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes

NCT04131582 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-10-21

No results posted yet for this study

Summary

Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face this health problem. The goal of this trial is to evaluate the effect of empagliflozin + linagliptin + metformin + lifestyle on physiopathological parameters, sush as glucose metabolism, insulin resistance, pancreatic beta cell function and cardiovascular function in patients with impaired fasting glucose plus impaired glucose tolerance, during 12 months

Conditions

Interventions

COMBINATION_PRODUCT

Linagliptin + metformin and Empagliflozin + metformin

Linagliptin-Metformin 2.5/850mg once daily, Empagliflozin-Metformin 12.5/850mg one daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling

DRUG

Metformin

Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling

Sponsors & Collaborators

  • Hospital Regional de Alta Especialidad del Bajio

    collaborator OTHER

  • Universidad de Guanajuato

    lead OTHER

Principal Investigators

  • Rodolfo Guardado-Mendoza, MDPhD · Universidad de Guanajuato

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-12-15
Completion
2020-12-30

Countries

  • Mexico

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04131582 on ClinicalTrials.gov