Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes mellitus type 2, degludec, glargine U300, glucose variability, lipids, arterial stiffness, oxidative stress
Brief 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.
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
Interventions
DRUGDegludec
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
DRUGGlargine U300
treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
Sponsors
Pavle Vrebalov Cindro
Jonatan Vuković
Darko Modun
Božo Smajić
Gordan Kardum
Tina Tičinović Kurir
Doris Rušić
Ana Šešelja Perišin
Josipa Bukić
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in glucose variability | 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 | 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 | 3 months | Oxidative stress will be assessed at the beginning and the end of each phase by measuring augmentation index with SphygmoCor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in HDL | 3 months | 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 |
| Changes from baseline in WBC | 3 months | White blood count will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit |
| Changes from baseline in RBC | 3 months | Red blood count will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit |
| Changes from baseline in platelets | 3 months | Platelets count will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit |
| Changes from baseline in hemoglobin | 3 months | 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 |
| Changes from baseline in total cholesterol | 3 months | 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 |
| Changes from baseline in MCV | 3 months | 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 |
| Changes from baseline in liver enzymes | 3 months | 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 |
| Changes from baseline in LDH | 3 months | 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 |
| Changes from baseline in ALP | 3 months | 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 |
| Changes from baseline in CRP | 3 months | 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 |
| Changes from baseline in hematocrit | 3 months | 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 |
| Changes from baseline in triglycerides | 3 months | 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 |
| Changes from baseline in LDL | 3 months | 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 |
Countries
Croatia
Outcome results
None listed