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

NCT03328845 | Completed Phase 4 DMC

• 1 other identifier: FIM-EOX-2016-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oxidation; Insulin analogues; Type 1 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Oxidative stress markers with the new slow insulin analogues

  To evaluate the impact on the circulating levels of oxidative stress markers of the different treatments using the new slow insulin analogues. 1a) Anti oxidation: Total antioxidant capacity (CAT), and 1b) Oxidation: 8-iso-prostaglandin F2 alpha (8-iso-PGF2α), thiobarbituric acid reactive substances (TBARS) and LDL-oxidized

  6 month

Secondary Outcomes (13)

• HbA1c

  6 month

• Mean blood glucose

  6 month

• Standard deviation

  6 month

• Number of mild hypoglycemia

  6 month

• Number of severe hypoglycemia

  6 month

Study Arms (6)

Tresiba & NovoRapid

OTHER

Patients treated with Tresiba insulin and NovoRapid insulin

Drug: Tresiba; Drug: NovoRapid

Toujeo SoloStar & NovoRapid

OTHER

Patients treated with Toujeo SoloStar insulin and NovoRapid insulin

Drug: Toujeo SoloStar; Drug: NovoRapid

Tresiba & Humalog Kwikpen

OTHER

Patients treated with Tresiba insulin and Humalog kwikpen insulin

Drug: Tresiba; Drug: Humalog Kwikpen

Toujeo SoloStar & Humalog Kwikpen

OTHER

Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin

Drug: Toujeo SoloStar; Drug: Humalog Kwikpen

Tresiba & Apidra

OTHER

Patients treated with Tresiba insulin and Apidra insulin

Drug: Tresiba; Drug: Apidra

Toujeo SoloStar & Apidra

OTHER

Patients treated with Toujeo SoloStar insulin and Apidra insulin

Drug: Toujeo SoloStar; Drug: Apidra

Interventions

Toujeo SoloStar DRUG

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

Also known as: Glargina U300

Toujeo SoloStar & Apidra; Toujeo SoloStar & Humalog Kwikpen; Toujeo SoloStar & NovoRapid

Tresiba DRUG

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

Also known as: Degludec insulin

Tresiba & Apidra; Tresiba & Humalog Kwikpen; Tresiba & NovoRapid

Humalog Kwikpen DRUG

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

Also known as: Lispro insulin

Toujeo SoloStar & Humalog Kwikpen; Tresiba & Humalog Kwikpen

NovoRapid DRUG

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

Also known as: Aspart insulin

Toujeo SoloStar & NovoRapid; Tresiba & NovoRapid

Apidra DRUG

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

Also known as: Glulisine insulin

Toujeo SoloStar & Apidra; Tresiba & Apidra

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
• Pregnancy or pregnancy planning.
• Diabetes mellitus type 2.
• Absence of collaboration (informed consent).

Sponsors & Collaborators

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

Study Sites (1)

Regional University Hospital of Málaga

Málaga, Spain

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec; Insulin Lispro; Insulin Aspart; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maria Soledad Ruiz de Adana

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 1, 2017
• Study Start: January 20, 2017
• Primary Completion: November 30, 2020
• Study Completion: November 20, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

ES (1)