CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Toujeo SoloStar +4 moredrug
Likely dose
Toujeo SoloStar 130 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03328845
NCT03328845Phase 4Completed

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

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud·interventional·Posted Nov 1, 2017·Updated Dec 6, 2021

In Brief

A Phase 4 clinical trial evaluating Toujeo SoloStar, Tresiba, and 3 other interventions for Type 1 Diabetes Mellitus. Completed, enrolled 300 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 1, 2017
Enrollment StartJan 20, 2017
Primary CompletionNov 30, 2020
Study CompletionNov 20, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.7 years ago

Interventions

Toujeo SoloStardrug

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

Tresibadrug

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

Humalog Kwikpendrug

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

NovoRapiddrug

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

Apidradrug

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