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

Phase 1

Conditions: DIABETES TYPE 1
MedDRA version: 19.0Level: PTClassification code 10022491Term: Insulin resistant diabetesSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2016-002915-17-ES

Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

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

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Study the relationship between the variables of glycemic control (HbA1c and mean blood glucose) and glycemic variability<br>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