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Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)

NCT03328845 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-12-06

No results posted yet for this study

Summary

This study evaluates in a group of people with DM 1 the influence in parameters of oxidative stress of the treatments with the different current analogs of insulin

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Toujeo SoloStar

Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.

DRUG

Tresiba

Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.

DRUG

Humalog Kwikpen

Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl

DRUG

NovoRapid

Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl

DRUG

Apidra

Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-20
Primary Completion
2020-11-30
Completion
2021-11-20

Countries

  • Spain

Study Locations

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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 NCT03328845 on ClinicalTrials.gov