Diabetes Mellitus, Type 2Phase 4NCT04692415
Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors
A Phase 4 study testing Degludec and Glargine U300 in people with Diabetes Mellitus, Type 2, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
To compare the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on cardiovascular risk parameters - glycaemic variability (GV), oxidative stress, arterial stiffness and lipid parameters - in insulin naive patients with DMT2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Degludec and Glargine U300
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Dec 2018to 27 Jun 2019
- 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
- a history of DMT2 for at least 1 year
- 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)
Who cannot join
- the presence of malignant disease
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Differences Between Insulin Glargine U300 and Insulin Degludec U100 in Impact on the Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles in Insulin naïve Patients Suffering From Type Two Diabetes Mellitus
To compare the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on cardiovascular risk parameters - glycaemic variability (GV), oxidative stress, arterial stiffness and lipid parameters - in insulin naive patients with DMT2.
Read the detailed description
We recruited a total of 25 patients (23 completed the study) with T2DM who had uncontrolled disease on two or more oral antidiabetic drugs. After the wash-up period, they were randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin. Each insulin was applied for 12 weeks. At the beginning and the end of each phase, biochemical and oxidative stress parameters were analysed and augmentation index was measured. On three consecutive days prior to each control point, patients performed a 7-point SMBG profile. Oxidative stress was assessed by measuring thiol groups and hydroperoxides (d-ROM) in serum. For augmentation index measuring, we used SphygmoCor (AtCor Medical, Sydney, Australia) which allow non-invasive measurement of AIx on radial artery using strain gauge transducer placed on the tip of a pencil-type tonometer. This method is based on the principle of applanation tonometry
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Degludec, Glargine U300
- Keywords
- Diabetes mellitus type 2, degludec, glargine U300, glucose variability, lipids, arterial stiffness, oxidative stress
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegludecDrug
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
Glargine U300Drug
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
| Study group | Role | What they receive |
|---|---|---|
| degludec arm | Active comparator | 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. Receives: Drug: Degludec |
| glargine arm | Active comparator | 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. Receives: Drug: Glargine U300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in glucose variability
Glucose variability will be assessed at the beginning and the end of each phase using 3-day 7-point SMBG and calculating coefficient of variation in % out of SMBG recordings
Measured: 3 months
Changes from baseline in oxidative stress
Oxidative stress will be assessed at the beginning and the end of each phase by measuring thiol groups and hydroperoxides (d-ROM) in serum
Measured: 3 months
Changes from baseline in arterial stiffness after treatment
Oxidative stress will be assessed at the beginning and the end of each phase by measuring augmentation index with SphygmoCor.
Measured: 3 months
Secondary outcomes (14)
Changes from baseline in total cholesterol
Total cholesterol concentration in mmol/L will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in triglycerides
Triglyceride concentration in mmol/L will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in LDL
Low density lipoprotein cholesterol concentration in mmol/L will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in HDL
High density lipoprotein cholesterol concentration in mmol/L will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in WBC
White blood count will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in RBC
Red blood count will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in platelets
Platelets count will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in hemoglobin
Hemoglobin concentration in g/L will be assessed in at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in hematocrit
Hematocrit in L/L will be assessed in at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in MCV
Medium cellular volume in fL will be assessed in at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in liver enzymes
ALT, AST and GGT concentration in U/L will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in LDH
Lactate dehydrogenase concentration in U/L will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in ALP
Alkaline phosphatase concentration in U/L will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Changes from baseline in CRP
C-reactive protein concentration in mg/L will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start15 Dec 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pavle Vrebalov Cindro, Jonatan Vuković, Darko Modun, Božo Smajić, Gordan Kardum, Tina Tičinović Kurir, Doris Rušić, Ana Šešelja Perišin, Josipa Bukić
- Responsible party
- Principal investigator, Mladen Krnic, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692415
- Sponsor's protocol ID
- 500-03/16-01/49
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: on request
Publications
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.
PubMed 10938048Eckel 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.
PubMed 11994264Ceriello 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.
PubMed 18299315Monnier 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.
PubMed 18227477Monnier 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.
PubMed 16609090Monnier 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.
PubMed 19885298Patoulias 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.
PubMed 32058679Vukovic 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.
PubMed 19457484Tamminen 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.
PubMed 14511356Gordin 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.
PubMed 31119456Aslan 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.
PubMed 23617853Home 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.
PubMed 15111525Heise 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.
PubMed 27593206Tibaldi 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.
PubMed 30552800Rosenstock 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.
PubMed 30104294
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differences Between Insulin Glargine U300 and Insulin Degludec U100 in Impact on the Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles in Insulin naïve Patients Suffering From Type Two Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04692415
- Acronym / sponsor ID
- 500-03/16-01/49
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes mellitus type 2, degludec, glargine U300, glucose variability, lipids, arterial stiffness, oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Collaborators
- Pavle Vrebalov Cindro, Jonatan Vuković, Darko Modun, Božo Smajić, Gordan Kardum, Tina Tičinović Kurir, Doris Rušić, Ana Šešelja Perišin, Josipa Bukić
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on cardiovascular risk parameters - glycaemic variability (GV), oxidative stress, arterial stiffness and lipid parameters - in insulin naive patients with DMT2.
Detailed description
We recruited a total of 25 patients (23 completed the study) with T2DM who had uncontrolled disease on two or more oral antidiabetic drugs. After the wash-up period, they were randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin. Each insulin was applied for 12 weeks. At the beginning and the end of each phase, biochemical and oxidative stress parameters were analysed and augmentation index was measured. On three consecutive days prior to each control point, patients performed a 7-point SMBG profile. Oxidative stress was assessed by measuring thiol groups and hydroperoxides (d-ROM) in serum. For augmentation index measuring, we used SphygmoCor (AtCor Medical, Sydney, Australia) which allow non-invasive measurement of AIx on radial artery using strain gauge transducer placed on the tip of a pencil-type tonometer. This method is based on the principle of applanation tonometry
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| degludec arm | Active comparator | Drug: Degludec25 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. |
| glargine arm | Active comparator | Drug: Glargine U30025 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- a history of DMT2 for at least 1 year
- 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%
Key exclusion criteria (5 listed)
- the presence of malignant disease
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Degludectreatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles | Drug | degludec arm |
| Glargine U300treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles | Drug | glargine arm |
Primary outcome
Changes from baseline in glucose variability
Time frame: 3 months
Glucose variability will be assessed at the beginning and the end of each phase using 3-day 7-point SMBG and calculating coefficient of variation in % out of SMBG recordings
Changes from baseline in oxidative stress
Time frame: 3 months
Oxidative stress will be assessed at the beginning and the end of each phase by measuring thiol groups and hydroperoxides (d-ROM) in serum
Changes from baseline in arterial stiffness after treatment
Time frame: 3 months
Oxidative stress will be assessed at the beginning and the end of each phase by measuring augmentation index with SphygmoCor.
14 secondary outcomes
Changes from baseline in total cholesterol
Time frame: 3 months
Changes from baseline in triglycerides
Time frame: 3 months
Changes from baseline in LDL
Time frame: 3 months
Changes from baseline in HDL
Time frame: 3 months
Changes from baseline in WBC
Time frame: 3 months
Changes from baseline in RBC
Time frame: 3 months
Changes from baseline in platelets
Time frame: 3 months
Changes from baseline in hemoglobin
Time frame: 3 months
Changes from baseline in hematocrit
Time frame: 3 months
Changes from baseline in MCV
Time frame: 3 months
Changes from baseline in liver enzymes
Time frame: 3 months
Changes from baseline in LDH
Time frame: 3 months
Changes from baseline in ALP
Time frame: 3 months
Changes from baseline in CRP
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Background: PubMed 10938048Stratton 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.
- Background: PubMed 11994264Eckel 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.
- Background: PubMed 18299315Ceriello 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.
- Background: PubMed 18227477Monnier 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.
- Background: PubMed 16609090Monnier 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.
- Background: PubMed 19885298Monnier 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.
- Background: PubMed 32058679Patoulias 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.
- Background: PubMed 19457484Vukovic 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.
- Background: PubMed 14511356Tamminen 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.
- Background: PubMed 31119456Gordin 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.
- Background: PubMed 23617853Aslan 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.
- Background: PubMed 15111525Home 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.
- Individual participant dataSharing planned: Yes. on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Degludec and Glargine U300 in people with Diabetes Mellitus, Type 2, run by University of Split, School of Medicine at 1 site in Croatia.
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 7 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 31 Dec 2020. 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 Croatia. 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?
Changes from baseline in glucose variability (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT04692415, which also lists 17 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 31 Dec 2020.