Clinical trial NCT04692415: Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus type 2
degludec
glargine U300
glucose variability
lipids
arterial stiffness
oxidative stress
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
Collaborators: name: Pavle Vrebalov Cindro
name: Jonatan Vuković
name: Darko Modun
name: Božo Smajić
name: Gordan Kardum
name: Tina Tičinović Kurir
name: Doris Rušić
name: Ana Šešelja Perišin
name: Josipa Bukić
First posted: 2020-12-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in glucose variability
timeFrame: 3 months
measure: Changes from baseline in oxidative stress
timeFrame: 3 months
measure: Changes from baseline in arterial stiffness after treatment
timeFrame: 3 months
Secondary outcomes:
measure: Changes from baseline in total cholesterol
timeFrame: 3 months
measure: Changes from baseline in triglycerides
timeFrame: 3 months
measure: Changes from baseline in LDL
timeFrame: 3 months
measure: Changes from baseline in HDL
timeFrame: 3 months
measure: Changes from baseline in WBC
timeFrame: 3 months
measure: Changes from baseline in RBC
timeFrame: 3 months
measure: Changes from baseline in platelets
timeFrame: 3 months
measure: Changes from baseline in hemoglobin
timeFrame: 3 months
measure: Changes from baseline in hematocrit
timeFrame: 3 months
measure: Changes from baseline in MCV
timeFrame: 3 months
measure: Changes from baseline in liver enzymes
timeFrame: 3 months
measure: Changes from baseline in LDH
timeFrame: 3 months
measure: Changes from baseline in ALP
timeFrame: 3 months
measure: Changes from baseline in CRP
timeFrame: 3 months
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Klinički bolnički Centar Split
Study officials:
References:
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