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Clinical Trial Details

Trial ID: L7040
Source ID: NCT03328845
Associated Drug: Toujeo Solostar
Title: Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)
Acronym: INEOX
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Toujeo SoloStar|DRUG: Tresiba|DRUG: Humalog Kwikpen|DRUG: NovoRapid|DRUG: Apidra
Outcome Measures: Primary: 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: HbA1c, Glycemic control: glycosylated hemoglobin, 6 month|Mean blood glucose, Glycemic control: mean blood glucose (mg/dl), 6 month|Standard deviation, Glycemic variability :standard deviation \[SD\], 6 month|Number of mild hypoglycemia, Number of mild hypoglycaemia in two weeks, 6 month|Number of severe hypoglycemia, Number of severe hypoglycemia in the last 6 months, 6 month|Number of hyperglycemia, Number of hyperglycemia\> 250 mg / dl in two weeks, 6 month|Episodes of ketosis, Episodes of ketosis in the last 6 months, 6 month|Number os hospital admissions, Number of hospital admissions for acute diabetes decompensation in the last 6 months., 6 month|Quality of life questionnaire in diabetes (DQOL), 34 items on the quality of life of people with type 1 diabetes, 6 month|Scale of adherence to treatment in patients with diabetes type 1 (DM1), 15 items related to adherence to patient treatment, 6 month|Diabetes distress scale. DDS, 17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005), 6 month|Fear of hypoglycemia: Questionnaire FH-15, 15 items related to the fear of hypoglycemia in patients with type 1 diabetes, 6 month|Diabetes treatment satisfaction questionnaire (DTSQ)., 8 items concerning the satisfaction of the treatment, 6 month
Sponsor/Collaborators: Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-01-20
Completion Date: 2021-11-20
Results First Posted:
Last Update Posted: 2021-12-06
Locations: Regional University Hospital of Málaga, Málaga, Spain
URL: https://clinicaltrials.gov/show/NCT03328845