Status:
COMPLETED
Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors
Lead Sponsor:
University of Split, School of Medicine
Collaborating Sponsors:
Pavle Vrebalov Cindro
Jonatan Vuković
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 lipi...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04692415
Start Date
December 15 2018
End Date
June 27 2019
Last Update
December 31 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Klinički bolnički Centar Split
Split, Croatia, 21000