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

• Status: Completed
• Trial end date: 2019-06-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Split, School of Medicine
• Collaborators: Ana Šešelja Perišin; Božo Smajić; Darko Modun; Doris Rušić; Gordan Kardum; Jonatan Vuković; Josipa Bukić; Pavle Vrebalov Cindro; Tina Tičinović Kurir
• Treatments: Insulin Glargine

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