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Completed

NCT Number: NCT04692415

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinički bolnički Centar Split

Split, 21000, Croatia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Degludec

Drug

treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles

Glargine U300

Drug

treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles

Primary outcomes

  1. Changes from baseline in glucose variability

    Time frame: 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

  2. Changes from baseline in oxidative stress

    Time frame: 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

  3. Changes from baseline in arterial stiffness after treatment

    Time frame: 3 months

    Oxidative stress will be assessed at the beginning and the end of each phase by measuring augmentation index with SphygmoCor.

Secondary outcomes

  1. Changes from baseline in total cholesterol

    Time frame: 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

  2. Changes from baseline in triglycerides

    Time frame: 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

  3. Changes from baseline in LDL

    Time frame: 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

  4. Changes from baseline in HDL

    Time frame: 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

  5. Changes from baseline in WBC

    Time frame: 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

  6. Changes from baseline in RBC

    Time frame: 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

  7. Changes from baseline in platelets

    Time frame: 3 months

    Platelets count will be assessed at the beginning and the end of each phase by the automatic analyzer and enzymatic laboratory kit

  8. Changes from baseline in hemoglobin

    Time frame: 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

  9. Changes from baseline in hematocrit

    Time frame: 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

  10. Changes from baseline in MCV

    Time frame: 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

  11. Changes from baseline in liver enzymes

    Time frame: 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

  12. Changes from baseline in LDH

    Time frame: 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

  13. Changes from baseline in ALP

    Time frame: 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

  14. Changes from baseline in CRP

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Collaborators

  • Ana Šešelja Perišin
  • Božo Smajić
  • Darko Modun
  • Doris Rušić
  • Gordan Kardum
  • Jonatan Vuković
  • Josipa Bukić
  • Pavle Vrebalov Cindro
  • Tina Tičinović Kurir

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 31, 2020
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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