Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study) (INEOX)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Toujeo SoloStar
Tresiba
Humalog Kwikpen
NovoRapid
Apidra
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Oxidation, Insulin analogues, Type 1 diabetes mellitus
Eligibility Criteria
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).
Sites / Locations
- Regional University Hospital of Málaga
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Other
Other
Other
Other
Other
Other
Arm Label
Tresiba & NovoRapid
Toujeo SoloStar & NovoRapid
Tresiba & Humalog Kwikpen
Toujeo SoloStar & Humalog Kwikpen
Tresiba & Apidra
Toujeo SoloStar & Apidra
Arm Description
Patients treated with Tresiba insulin and NovoRapid insulin
Patients treated with Toujeo SoloStar insulin and NovoRapid insulin
Patients treated with Tresiba insulin and Humalog kwikpen insulin
Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
Patients treated with Tresiba insulin and Apidra insulin
Patients treated with Toujeo SoloStar insulin and Apidra insulin
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
HbA1c
Glycemic control: glycosylated hemoglobin
Mean blood glucose
Glycemic control: mean blood glucose (mg/dl)
Standard deviation
Glycemic variability :standard deviation [SD]
Number of mild hypoglycemia
Number of mild hypoglycaemia in two weeks
Number of severe hypoglycemia
Number of severe hypoglycemia in the last 6 months
Number of hyperglycemia
Number of hyperglycemia> 250 mg / dl in two weeks
Episodes of ketosis
Episodes of ketosis in the last 6 months
Number os hospital admissions
Number of hospital admissions for acute diabetes decompensation in the last 6 months.
Quality of life questionnaire in diabetes (DQOL)
34 items on the quality of life of people with type 1 diabetes
Scale of adherence to treatment in patients with diabetes type 1 (DM1)
15 items related to adherence to patient treatment
Diabetes distress scale. DDS
17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005)
Fear of hypoglycemia: Questionnaire FH-15
15 items related to the fear of hypoglycemia in patients with type 1 diabetes
Diabetes treatment satisfaction questionnaire (DTSQ).
8 items concerning the satisfaction of the treatment
Full Information
NCT ID
NCT03328845
First Posted
October 29, 2017
Last Updated
November 23, 2021
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
1. Study Identification
Unique Protocol Identification Number
NCT03328845
Brief Title
Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)
Acronym
INEOX
Official Title
Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. Clinical Trial of Low Level of Intervention. (Ineox Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed 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:
- 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.
- 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Oxidation, Insulin analogues, Type 1 diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tresiba & NovoRapid
Arm Type
Other
Arm Description
Patients treated with Tresiba insulin and NovoRapid insulin
Arm Title
Toujeo SoloStar & NovoRapid
Arm Type
Other
Arm Description
Patients treated with Toujeo SoloStar insulin and NovoRapid insulin
Arm Title
Tresiba & Humalog Kwikpen
Arm Type
Other
Arm Description
Patients treated with Tresiba insulin and Humalog kwikpen insulin
Arm Title
Toujeo SoloStar & Humalog Kwikpen
Arm Type
Other
Arm Description
Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
Arm Title
Tresiba & Apidra
Arm Type
Other
Arm Description
Patients treated with Tresiba insulin and Apidra insulin
Arm Title
Toujeo SoloStar & Apidra
Arm Type
Other
Arm Description
Patients treated with Toujeo SoloStar insulin and Apidra insulin
Intervention Type
Drug
Intervention Name(s)
Toujeo SoloStar
Other Intervention Name(s)
Glargina U300
Intervention Description
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Intervention Type
Drug
Intervention Name(s)
Tresiba
Other Intervention Name(s)
Degludec insulin
Intervention Description
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Intervention Type
Drug
Intervention Name(s)
Humalog Kwikpen
Other Intervention Name(s)
Lispro insulin
Intervention Description
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Intervention Type
Drug
Intervention Name(s)
NovoRapid
Other Intervention Name(s)
Aspart insulin
Intervention Description
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Intervention Type
Drug
Intervention Name(s)
Apidra
Other Intervention Name(s)
Glulisine insulin
Intervention Description
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Primary Outcome Measure Information:
Title
Oxidative stress markers with the new slow insulin analogues
Description
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
Time Frame
6 month
Secondary Outcome Measure Information:
Title
HbA1c
Description
Glycemic control: glycosylated hemoglobin
Time Frame
6 month
Title
Mean blood glucose
Description
Glycemic control: mean blood glucose (mg/dl)
Time Frame
6 month
Title
Standard deviation
Description
Glycemic variability :standard deviation [SD]
Time Frame
6 month
Title
Number of mild hypoglycemia
Description
Number of mild hypoglycaemia in two weeks
Time Frame
6 month
Title
Number of severe hypoglycemia
Description
Number of severe hypoglycemia in the last 6 months
Time Frame
6 month
Title
Number of hyperglycemia
Description
Number of hyperglycemia> 250 mg / dl in two weeks
Time Frame
6 month
Title
Episodes of ketosis
Description
Episodes of ketosis in the last 6 months
Time Frame
6 month
Title
Number os hospital admissions
Description
Number of hospital admissions for acute diabetes decompensation in the last 6 months.
Time Frame
6 month
Title
Quality of life questionnaire in diabetes (DQOL)
Description
34 items on the quality of life of people with type 1 diabetes
Time Frame
6 month
Title
Scale of adherence to treatment in patients with diabetes type 1 (DM1)
Description
15 items related to adherence to patient treatment
Time Frame
6 month
Title
Diabetes distress scale. DDS
Description
17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005)
Time Frame
6 month
Title
Fear of hypoglycemia: Questionnaire FH-15
Description
15 items related to the fear of hypoglycemia in patients with type 1 diabetes
Time Frame
6 month
Title
Diabetes treatment satisfaction questionnaire (DTSQ).
Description
8 items concerning the satisfaction of the treatment
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Regional University Hospital of Málaga
City
Málaga
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)
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