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

University of Split

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Degludec; Drug: Glargine U300

Study type: Interventional

Funder types: Other

Identifiers

NCT04692415

500-03/16-01/49

Details and patient eligibility

About

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.

Full 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

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

degludec arm

Active Comparator group

Description:

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.

Treatment:

Drug: Degludec

glargine arm

Active Comparator group

Description:

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.

Treatment:

Drug: Glargine U300