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Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine

NCT04088461 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-09-13

No results posted yet for this study

Summary

The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Main outcomes will be glucose levels during OGTT, insulin secretion and pancreatic beta cell function measured by the disposition index derived from the OGTT.

Conditions

Interventions

DRUG

Linagliptin / Metformin Oral Tablet

Linagliptin 2.5 mg + Metformin 850 mg twice daily plus a lifestyle modifications program

DRUG

Metformin

Metformin 850 mg twice daily plus lifestyle modifications program

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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Mexico

Study Locations

More Related Trials

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 NCT04088461 on ClinicalTrials.gov