Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Glargine U300Drug: Degludec
- Registration Number
- NCT04692415
- Lead Sponsor
- University of Split, School of Medicine
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description glargine arm Glargine U300 25 patients were discontinued their previous therapy and given metformin alone (2 g/day) for seven days. After seven days they were randomized to first receive IGlar-300 In phase one they received IGlar-300 and metformin for 12 weeks. Phase one was followed by a second wash-up period in which patients received metformin alone again for seven days. In phase two, which also lasted for 12 weeks, patients were switched from IGlar-300 to IDeg-100 (and metformin was continued). The initial dose of both insulins was 0.2 IU/kg. degludec arm Degludec 25 patients were discontinued their previous therapy and given metformin alone (2 g/day) for seven days. After seven days they were randomized to first receive IDeg-100 In phase one they received IDeg-100 and metformin for 12 weeks. Phase one was followed by a second wash-up period in which patients received metformin alone again for seven days. In phase two, which also lasted for 12 weeks, patients were switched from IDeg-100 to IGlar-300 (and metformin was continued). The initial dose of both insulins was 0.2 IU/kg.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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
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 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 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 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 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 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 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 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
Trial Locations
- Locations (1)
Klinički bolnički Centar Split
🇭🇷Split, Croatia