Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors

University of Split, School of Medicine25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinički bolnički Centar Split

Split, Croatia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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