Diabetes Mellitus, Type 2 Clinical Trial
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
Verified date | December 2020 |
Source | University of Split, School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 27, 2019 |
Est. primary completion date | June 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Klinicki bolnicki Centar Split | Split |
Lead Sponsor | Collaborator |
---|---|
University of Split, School of Medicine | Ana Šešelja Perišin, Božo Smajic, Darko Modun, Doris Rušic, Gordan Kardum, Jonatan Vukovic, Josipa Bukic, Pavle Vrebalov Cindro, Tina Ticinovic Kurir |
Croatia,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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