A Phase 4 interventional study of Degludec and Glargine U300 in Diabetes Mellitus, Type 2, sponsored by University of Split, School of Medicine. Completed at 1 site in Croatia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-31.
Sponsored by University of Split, School of Medicine · Phase 4, Interventional, and Treatment
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.
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 25 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion criteria:
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.
Drug: Degludec
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.
Drug: Glargine U300
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
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
Time frame: 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
Time frame: 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.
Time frame: 3 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months
Plan to share: Yes — on request
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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University of Split, School of Medicine