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Clinical Trial Details

Trial ID: L5773
Source ID: NCT04692415
Associated Drug: Degludec
Title: Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Degludec|DRUG: Glargine U300
Outcome Measures: Primary: 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, 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, 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., 3 months | Secondary: 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 3 months
Sponsor/Collaborators: Sponsor: University of Split, School of Medicine | Collaborators: Pavle Vrebalov Cindro|Jonatan Vuković|Darko Modun|Božo Smajić|Gordan Kardum|Tina Tičinović Kurir|Doris Rušić|Ana Šešelja Perišin|Josipa Bukić
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-12-15
Completion Date: 2019-06-27
Results First Posted:
Last Update Posted: 2020-12-31
Locations: Klinički bolnički Centar Split, Split, 21000, Croatia
URL: https://clinicaltrials.gov/show/NCT04692415