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Search / Trial NCT04692415

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

Launched by UNIVERSITY OF SPLIT, SCHOOL OF MEDICINE · Dec 29, 2020

Trial Information

Current as of July 21, 2025

Completed

Keywords

Diabetes Mellitus Type 2 Degludec Glargine U300 Glucose Variability Lipids Arterial Stiffness Oxidative Stress

ClinConnect Summary

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 group...

Gender

ALL

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

About University Of Split, School Of Medicine

The University of Split, School of Medicine is a leading academic institution dedicated to advancing medical education, research, and clinical practice. Committed to fostering innovation and improving patient care, the School conducts rigorous clinical trials that explore cutting-edge therapies and interventions. With a focus on collaboration and multidisciplinary approaches, the institution aims to translate research findings into practical applications, enhancing healthcare outcomes both locally and globally. Through its robust infrastructure and expertise, the University of Split School of Medicine strives to contribute significantly to the medical field and the well-being of the community.

Locations

Split, , Croatia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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