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Type 1 Diabetes MellitusPhase 4INEOXNCT03328845

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

A Phase 4 study testing Toujeo SoloStar, Tresiba and Humalog Kwikpen in people with Type 1 Diabetes Mellitus, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Toujeo SoloStar, Tresiba and Humalog Kwikpen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteSpain
Study dates
20 Jan 2017to 20 Nov 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • Regional University Hospital of Málaga

    Málaga

Other trials in Spain

About this study

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)

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

Read the 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:

  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).

Being tested
Toujeo SoloStar, Tresiba, Humalog Kwikpen, NovoRapid, Apidra
Keywords
Oxidation, Insulin analogues, Type 1 diabetes mellitus
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Toujeo SoloStarDrug

    Also called Glargina U300

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

  • TresibaDrug

    Also called Degludec insulin

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

  • Humalog KwikpenDrug

    Also called Lispro insulin

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

  • NovoRapidDrug

    Also called Aspart insulin

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

  • ApidraDrug

    Also called Glulisine insulin

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

Study groups in NCT03328845
Study groupRoleWhat they receive
Tresiba & NovoRapidOtherPatients treated with Tresiba insulin and NovoRapid insulin
Receives: Drug: Tresiba; Drug: NovoRapid
Toujeo SoloStar & NovoRapidOtherPatients treated with Toujeo SoloStar insulin and NovoRapid insulin
Receives: Drug: Toujeo SoloStar; Drug: NovoRapid
Tresiba & Humalog KwikpenOtherPatients treated with Tresiba insulin and Humalog kwikpen insulin
Receives: Drug: Tresiba; Drug: Humalog Kwikpen
Toujeo SoloStar & Humalog KwikpenOtherPatients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
Receives: Drug: Toujeo SoloStar; Drug: Humalog Kwikpen
Tresiba & ApidraOtherPatients treated with Tresiba insulin and Apidra insulin
Receives: Drug: Tresiba; Drug: Apidra
Toujeo SoloStar & ApidraOtherPatients treated with Toujeo SoloStar insulin and Apidra insulin
Receives: Drug: Toujeo SoloStar; Drug: Apidra

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 month

Secondary outcomes (13)

  1. HbA1c

    Glycemic control: glycosylated hemoglobin

    Measured: 6 month

  2. Mean blood glucose

    Glycemic control: mean blood glucose (mg/dl)

    Measured: 6 month

  3. Standard deviation

    Glycemic variability :standard deviation [SD]

    Measured: 6 month

  4. Number of mild hypoglycemia

    Number of mild hypoglycaemia in two weeks

    Measured: 6 month

  5. Number of severe hypoglycemia

    Number of severe hypoglycemia in the last 6 months

    Measured: 6 month

  6. Number of hyperglycemia

    Number of hyperglycemia> 250 mg / dl in two weeks

    Measured: 6 month

  7. Episodes of ketosis

    Episodes of ketosis in the last 6 months

    Measured: 6 month

  8. Number os hospital admissions

    Number of hospital admissions for acute diabetes decompensation in the last 6 months.

    Measured: 6 month

  9. Quality of life questionnaire in diabetes (DQOL)

    34 items on the quality of life of people with type 1 diabetes

    Measured: 6 month

  10. Scale of adherence to treatment in patients with diabetes type 1 (DM1)

    15 items related to adherence to patient treatment

    Measured: 6 month

  11. Diabetes distress scale. DDS

    17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005)

    Measured: 6 month

  12. Fear of hypoglycemia: Questionnaire FH-15

    15 items related to the fear of hypoglycemia in patients with type 1 diabetes

    Measured: 6 month

  13. Diabetes treatment satisfaction questionnaire (DTSQ).

    8 items concerning the satisfaction of the treatment

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start20 Jan 2017
  3. Primary completion30 Nov 2020
  4. Study completion20 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03328845
Sponsor's protocol ID
FIM-EOX-2016-01
Acronym
INEOX
Status last verified
Nov 2021
First submitted
29 Oct 2017
Last updated
6 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Aljada A, Ghanim H, Saadeh R, Dandona P. Insulin inhibits NFkappaB and MCP-1 expression in human aortic endothelial cells. J Clin Endocrinol Metab. 2001 Jan;86(1):450-3. doi: 10.1210/jcem.86.1.7278.

    PubMed 11232040

  • Arufe MC, Lu M, Lin RY. Differentiation of murine embryonic stem cells to thyrocytes requires insulin and insulin-like growth factor-1. Biochem Biophys Res Commun. 2009 Apr 3;381(2):264-70. doi: 10.1016/j.bbrc.2009.02.035. Epub 2009 Feb 14.

    PubMed 19232325

  • Bashan N, Kovsan J, Kachko I, Ovadia H, Rudich A. Positive and negative regulation of insulin signaling by reactive oxygen and nitrogen species. Physiol Rev. 2009 Jan;89(1):27-71. doi: 10.1152/physrev.00014.2008.

    PubMed 19126754

  • Baynes JW. Role of oxidative stress in development of complications in diabetes. Diabetes. 1991 Apr;40(4):405-12. doi: 10.2337/diab.40.4.405.

    PubMed 2010041

  • Baynes JW, Thorpe SR. Role of oxidative stress in diabetic complications: a new perspective on an old paradigm. Diabetes. 1999 Jan;48(1):1-9. doi: 10.2337/diabetes.48.1.1.

    PubMed 9892215

  • Berg TJ, Nourooz-Zadeh J, Wolff SP, Tritschler HJ, Bangstad HJ, Hanssen KF. Hydroperoxides in plasma are reduced by intensified insulin treatment. A randomized controlled study of IDDM patients with microalbuminuria. Diabetes Care. 1998 Aug;21(8):1295-300. doi: 10.2337/diacare.21.8.1295.

    PubMed 9702436

  • Bergenstal RM, Bailey TS, Rodbard D, Ziemen M, Guo H, Muehlen-Bartmer I, Ahmann AJ. Comparison of Insulin Glargine 300 Units/mL and 100 Units/mL in Adults With Type 1 Diabetes: Continuous Glucose Monitoring Profiles and Variability Using Morning or Evening Injections. Diabetes Care. 2017 Apr;40(4):554-560. doi: 10.2337/dc16-0684. Epub 2017 Jan 23.

    PubMed 28115474

  • Bode BW, Buse JB, Fisher M, Garg SK, Marre M, Merker L, Renard E, Russell-Jones DL, Hansen CT, Rana A, Heller SR; BEGIN(R) Basal-Bolus Type 1 trial investigators. Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN((R)) Basal-Bolus Type 1): 2-year results of a randomized clinical trial. Diabet Med. 2013 Nov;30(11):1293-7. doi: 10.1111/dme.12243. Epub 2013 Jun 17.

    PubMed 23710902

  • Bravi MC, Armiento A, Laurenti O, Cassone-Faldetta M, De Luca O, Moretti A, De Mattia G. Insulin decreases intracellular oxidative stress in patients with type 2 diabetes mellitus. Metabolism. 2006 May;55(5):691-5. doi: 10.1016/j.metabol.2006.01.003.

    PubMed 16631447

  • Brownlee M. The pathobiology of diabetic complications: a unifying mechanism. Diabetes. 2005 Jun;54(6):1615-25. doi: 10.2337/diabetes.54.6.1615. No abstract available.

    PubMed 15919781

  • Ceolotto G, Bevilacqua M, Papparella I, Baritono E, Franco L, Corvaja C, Mazzoni M, Semplicini A, Avogaro A. Insulin generates free radicals by an NAD(P)H, phosphatidylinositol 3'-kinase-dependent mechanism in human skin fibroblasts ex vivo. Diabetes. 2004 May;53(5):1344-51. doi: 10.2337/diabetes.53.5.1344.

    PubMed 15111505

  • Ceriello A. Hyperglycaemia and the vessel wall: the pathophysiological aspects on the atherosclerotic burden in patients with diabetes. Eur J Cardiovasc Prev Rehabil. 2010 May;17 Suppl 1:S15-9. doi: 10.1097/01.hjr.0000368193.24732.66.

    PubMed 20489415

  • Ceriello A, Esposito K, Ihnat M, Thorpe J, Giugliano D. Effect of acute hyperglycaemia, long-term glycaemic control and insulin on endothelial dysfunction and inflammation in Type 1 diabetic patients with different characteristics. Diabet Med. 2010 Aug;27(8):911-7. doi: 10.1111/j.1464-5491.2009.02928.x.

    PubMed 20653749

  • Ceriello A, Ihnat M. Oxidative stress is, convincingly, the mediator of the dangerous effects of glucose variability. Diabet Med. 2010 Aug;27(8):968. doi: 10.1111/j.1464-5491.2010.02931.x. No abstract available.

    PubMed 20653758

  • Ceriello A, Novials A, Ortega E, Canivell S, La Sala L, Pujadas G, Esposito K, Giugliano D, Genovese S. Glucagon-like peptide 1 reduces endothelial dysfunction, inflammation, and oxidative stress induced by both hyperglycemia and hypoglycemia in type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2346-50. doi: 10.2337/dc12-2469. Epub 2013 Apr 5.

    PubMed 23564922

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Toujeo SoloStar, Tresiba and Humalog Kwikpen in people with Type 1 Diabetes Mellitus, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxidative stress markers with the new slow insulin analogues (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03328845, which also lists 71 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

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