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

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

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Toujeo SoloStar; Drug: Humalog Kwikpen; Drug: Apidra; Drug: Tresiba; Drug: NovoRapid

Study type: Interventional

Funder types: Other

Identifiers

NCT03328845

FIM-EOX-2016-01

Details and patient eligibility

About

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

Full description

To evaluate by a randomized study 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 by analyzing:

1. • The circulating levels of oxidative stress markers: A) Anti oxidation: Total antioxidant capacity (CAT), B) Oxidation: 8-iso-prostaglandin F2 alpha (8-iso-PGF2α), acid reactive substances Thiobarbituric (TBARS) and LDL-oxidized.
2. • The relationship between glycemic control variables (HbA1c and mean glycemia) and variability (Standard deviation (SD), coefficient of variation (CV), and MAGE (mean amplitude of Glycemic excursions) and oxidative stress parameters analyzed.

Goal 2:

Study the activation of cellular pathways associated with processes and oxidation states, by means of a Array of expression of up to 50 genes encoding oxidative stress response genes as CPT1a (Carnitine Palmitoyl Transferase 1a, mitochondrial oxidizing b limiting enzyme), TAS (Fatty acyl synthetase), acetyl-coA carboxylase, Acadm (medium chain acyl dehydrogenase), Acadl (long chain acyl dehydrogenase), Acadvl (long chain acyl coA dehydrogenase), SOD1, Hmox1 and Glutamine-Cysteine ligase (Gclc).

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 years and 65 years (inclusive).
• DM1 of more than two years of evolution with habitual follow-up in the Diabetes Unit of the University Regional Hospital of Malaga.
• HbA1c ≤ 10%
• Intensive treatment with basal MDI - Bowl for more than 12 months prior to the start of study.
• Gives informed consent.

Exclusion criteria

• Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
• Pregnancy or pregnancy planning.
• Diabetes mellitus type 2.
• Hyperuricemia (uric acid ≥7 mg / dl at the time of inclusion or current treatment With allopurinol).
• Absence of collaboration (informed consent).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 6 patient groups

Tresiba & NovoRapid

Other group

Description:

Patients treated with Tresiba insulin and NovoRapid insulin

Treatment:

Drug: Tresiba

Drug: NovoRapid

Toujeo SoloStar & NovoRapid

Other group

Description:

Patients treated with Toujeo SoloStar insulin and NovoRapid insulin

Treatment:

Drug: NovoRapid

Drug: Toujeo SoloStar

Tresiba & Humalog Kwikpen

Other group

Description:

Patients treated with Tresiba insulin and Humalog kwikpen insulin

Treatment:

Drug: Humalog Kwikpen

Drug: Tresiba

Toujeo SoloStar & Humalog Kwikpen

Other group

Description:

Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin

Treatment:

Drug: Humalog Kwikpen

Drug: Toujeo SoloStar

Tresiba & Apidra

Other group

Description:

Patients treated with Tresiba insulin and Apidra insulin

Treatment:

Drug: Tresiba

Drug: Apidra

Toujeo SoloStar & Apidra

Other group

Description:

Patients treated with Toujeo SoloStar insulin and Apidra insulin

Treatment:

Drug: Apidra

Drug: Toujeo SoloStar