Study of the effect of novel analogues of insulin in people with type 1 diabetes

Impact on oxidative stress of novel analogues of insulin in people with type 1 diabetes. Low- intervention clinical trial. Ineox Study - INEOX

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002915-17-ES

Enrollment

300

Registered

2016-08-25

Start date

2016-11-03

Completion date

Unknown

Last updated

2016-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DIABETES TYPE 1 MedDRA version: 19.0 Level: PT Classification code 10022491 Term: Insulin resistant diabetes System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: TOUJEO Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN GLARGINE CAS Number: 160337-95-1 Current Sponsor code: insulin glargine Trade Name: TRES

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Aged between 18 and 65 (inclusive). - DM1 more than two years of development - HbA1c = 10% - Intensive treatment with MDI basal -Bolus for more than 12 months prior to baseline. - Gives informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: - Chronic kidney disease, liver disease, thyroid dysfunction (hypothyroidism except properly treated and controlled). - Pregnant or planning pregnancy. - Diabetes mellitus type 2. - Hyperuricemia (uric acid =7 mg / dl at the time of inclusion or current treatment with allopurinol). - Absence of consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the impact on circulating levels of oxidative stress markers of different treatments using novel slow insulin analogues;Secondary Objective: 1. Study the relationship between the variables of glycemic control (HbA1c and mean blood glucose) and glycemic variability 2. Study activating cellular processes and routes associated with oxidation states, by an array of expression of 50 genes encoding genes of oxidative stress response;Primary end point(s): Assess the impact on circulating levels of oxidative stress markers of different treatments using novel slow insulin analogues;Timepoint(s) of evaluation of this end point: 4th week and 24th week	—

Measure

Time frame

Main Objective: Assess the impact on circulating levels of oxidative stress markers of different treatments using novel slow insulin analogues;Secondary Objective: 1. Study the relationship between the variables of glycemic control (HbA1c and mean blood glucose) and glycemic variability 2. Study activating cellular processes and routes associated with oxidation states, by an array of expression of 50 genes encoding genes of oxidative stress response;Primary end point(s): Assess the impact on circulating levels of oxidative stress markers of different treatments using novel slow insulin analogues;Timepoint(s) of evaluation of this end point: 4th week and 24th week

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Study the relationship between the variables of glycemic control (HbA1c and mean blood glucose) and glycemic variability 2. Study activating cellular processes and routes associated with oxidation states, by an array of expression of 50 genes encoding genes of oxidative stress response;Timepoint(s) of evaluation of this end point: 4th week and 24th week	—

Countries

Spain

Contacts

Public ContactEstudios Clinicos. 7ª plant

FIMABIS

gloria.luque@fimabis.org34951291977

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026