Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors
NCT ID: NCT04692415
Last Updated: 2020-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
25 participants
INTERVENTIONAL
2018-12-15
2019-06-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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degludec arm
25 patients were discontinued their previous therapy and given metformin alone (2 g/day) for seven days. After seven days they were randomized to first receive IDeg-100 In phase one they received IDeg-100 and metformin for 12 weeks. Phase one was followed by a second wash-up period in which patients received metformin alone again for seven days. In phase two, which also lasted for 12 weeks, patients were switched from IDeg-100 to IGlar-300 (and metformin was continued). The initial dose of both insulins was 0.2 IU/kg.
Degludec
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
glargine arm
25 patients were discontinued their previous therapy and given metformin alone (2 g/day) for seven days. After seven days they were randomized to first receive IGlar-300 In phase one they received IGlar-300 and metformin for 12 weeks. Phase one was followed by a second wash-up period in which patients received metformin alone again for seven days. In phase two, which also lasted for 12 weeks, patients were switched from IGlar-300 to IDeg-100 (and metformin was continued). The initial dose of both insulins was 0.2 IU/kg.
Glargine U300
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
Interventions
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Degludec
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
Glargine U300
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
Eligibility Criteria
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Inclusion Criteria
* aged between 18 and 65 years (women obligatory postmenopausal)
* uncontrolled glycaemia on two or more oral antidiabetic drugs
* no prior use of insulin
* HbA1c ≥7.5%
* receiving statins (if not on statins, they were put on it)
* not on antiaggregant therapy (if on antiaggregants, they were temporarily excluded from therapy)
Exclusion Criteria
* chronic liver disease
* renal impairment with creatinine clearance \< 60 ml/s
* severe cardiovascular disease or history of cardiovascular incidents (stroke, myocardial infarction, peripheral amputation)
* rheumatic and autoimmune diseases and the usage of glitazones or anticoagulant therapy
18 Years
65 Years
ALL
No
Sponsors
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Pavle Vrebalov Cindro
UNKNOWN
Jonatan Vuković
UNKNOWN
Darko Modun
UNKNOWN
Božo Smajić
UNKNOWN
Gordan Kardum
UNKNOWN
Tina Tičinović Kurir
UNKNOWN
Doris Rušić
UNKNOWN
Ana Šešelja Perišin
UNKNOWN
Josipa Bukić
UNKNOWN
University of Split, School of Medicine
OTHER
Responsible Party
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Mladen Krnic
Assistant professor
Locations
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Klinički bolnički Centar Split
Split, , Croatia
Countries
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References
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Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
Eckel RH, Wassef M, Chait A, Sobel B, Barrett E, King G, Lopes-Virella M, Reusch J, Ruderman N, Steiner G, Vlassara H. Prevention Conference VI: Diabetes and Cardiovascular Disease: Writing Group II: pathogenesis of atherosclerosis in diabetes. Circulation. 2002 May 7;105(18):e138-43. doi: 10.1161/01.cir.0000013954.65303.c5. No abstract available.
Ceriello A, Esposito K, Piconi L, Ihnat MA, Thorpe JE, Testa R, Boemi M, Giugliano D. Oscillating glucose is more deleterious to endothelial function and oxidative stress than mean glucose in normal and type 2 diabetic patients. Diabetes. 2008 May;57(5):1349-54. doi: 10.2337/db08-0063. Epub 2008 Feb 25.
Monnier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care. 2008 Feb;31 Suppl 2:S150-4. doi: 10.2337/dc08-s241.
Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. doi: 10.1001/jama.295.14.1681.
Monnier L, Colette C, Owens DR. Glycemic variability: the third component of the dysglycemia in diabetes. Is it important? How to measure it? J Diabetes Sci Technol. 2008 Nov;2(6):1094-100. doi: 10.1177/193229680800200618.
Patoulias D, Papadopoulos C, Stavropoulos K, Zografou I, Doumas M, Karagiannis A. Prognostic value of arterial stiffness measurements in cardiovascular disease, diabetes, and its complications: The potential role of sodium-glucose co-transporter-2 inhibitors. J Clin Hypertens (Greenwich). 2020 Apr;22(4):562-571. doi: 10.1111/jch.13831. Epub 2020 Feb 14.
Vukovic J, Modun D, Budimir D, Sutlovic D, Salamunic I, Zaja I, Boban M. Acute, food-induced moderate elevation of plasma uric acid protects against hyperoxia-induced oxidative stress and increase in arterial stiffness in healthy humans. Atherosclerosis. 2009 Nov;207(1):255-60. doi: 10.1016/j.atherosclerosis.2009.04.012. Epub 2009 Apr 17.
Tamminen MK, Westerbacka J, Vehkavaara S, Yki-Jarvinen H. Insulin therapy improves insulin actions on glucose metabolism and aortic wave reflection in type 2 diabetic patients. Eur J Clin Invest. 2003 Oct;33(10):855-60. doi: 10.1046/j.1365-2362.2003.01220.x.
Gordin D, Saraheimo M, Tuomikangas J, Soro-Paavonen A, Forsblom C, Paavonen K, Steckel-Hamann B, Harjutsalo V, Nicolaou L, Pavo I, Koivisto V, Groop PH. Insulin exposure mitigates the increase of arterial stiffness in patients with type 2 diabetes and albuminuria: an exploratory analysis. Acta Diabetol. 2019 Nov;56(11):1169-1175. doi: 10.1007/s00592-019-01351-4. Epub 2019 May 22.
Aslan I, Kucuksayan E, Aslan M. Effect of insulin analog initiation therapy on LDL/HDL subfraction profile and HDL associated enzymes in type 2 diabetic patients. Lipids Health Dis. 2013 Apr 24;12:54. doi: 10.1186/1476-511X-12-54.
Home P, Bartley P, Russell-Jones D, Hanaire-Broutin H, Heeg JE, Abrams P, Landin-Olsson M, Hylleberg B, Lang H, Draeger E; Study to Evaluate the Administration of Detemir Insulin Efficacy, Safety and Suitability (STEADINESS) Study Group. Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial. Diabetes Care. 2004 May;27(5):1081-7. doi: 10.2337/diacare.27.5.1081.
Heise T, Mathieu C. Impact of the mode of protraction of basal insulin therapies on their pharmacokinetic and pharmacodynamic properties and resulting clinical outcomes. Diabetes Obes Metab. 2017 Jan;19(1):3-12. doi: 10.1111/dom.12782. Epub 2016 Sep 26.
Tibaldi J, Hadley-Brown M, Liebl A, Haldrup S, Sandberg V, Wolden ML, Rodbard HW. A comparative effectiveness study of degludec and insulin glargine 300 U/mL in insulin-naive patients with type 2 diabetes. Diabetes Obes Metab. 2019 Apr;21(4):1001-1009. doi: 10.1111/dom.13616. Epub 2019 Jan 8.
Rosenstock J, Cheng A, Ritzel R, Bosnyak Z, Devisme C, Cali AMG, Sieber J, Stella P, Wang X, Frias JP, Roussel R, Bolli GB. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. Diabetes Care. 2018 Oct;41(10):2147-2154. doi: 10.2337/dc18-0559. Epub 2018 Aug 13.
Vrebalov Cindro P, Krnic M, Modun D, Vukovic J, Ticinovic Kurir T, Kardum G, Rusic D, Seselja Perisin A, Bukic J. Comparison of the Impact of Insulin Degludec U100 and Insulin Glargine U300 on Glycemic Variability and Oxidative Stress in Insulin-Naive Patients With Type 2 Diabetes Mellitus: Pilot Study for a Randomized Trial. JMIR Form Res. 2022 Jul 8;6(7):e35655. doi: 10.2196/35655.
Cindro PV, Krnic M, Modun D, Smajic B, Vukovic J. The differences between insulin glargine U300 and insulin degludec U100 in impact on the glycaemic variability, arterial stiffness and the lipid profiles in insulin naive patients suffering from type two diabetes mellitus - outcomes from cross-over open-label randomized trial. BMC Endocr Disord. 2021 Apr 29;21(1):86. doi: 10.1186/s12902-021-00746-1.
Other Identifiers
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500-03/16-01/49
Identifier Type: -
Identifier Source: org_study_id