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

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

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

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