De-intensification of intensive insulin therapy using the combination of long-acting insulin glargin and GLP-1 receptor agonist lixisenatide
- Conditions
- Type 2 diabetes mellitusTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2020-003715-94-HU
- Lead Sponsor
- Békés Megyei Központi Kórház
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
•Type 2 diabetes mellitus
•Intensive insulin therapy with at least 3 doses of prandial insulin and one dose of basal insulin/day for at least 3 months prior to screening
•Total daily insulin dose = 0.8 IU/kg
•Fasting C peptide above the lower limit of the normal range
•Treatment with metformin (unless intolerance to metformin use is present)
•HbA1c = 75 mmol/mol (9%)
•HbA1c 76-86 mmol/mol (9.1-10%) in case of proven non-compliance with MDI regimen
•Age 18-80 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
•Other diabetes types – type 1, secondary
•Any contraindication to the use of GLP-1 receptor agonists
•Daily dose of basal insulin >50 units/day
•Acute myocardial infarction, unstable angina pectoris, stroke, pulmonary embolism 3 months prior to inclusion
•Chronic heart failure NYHA III-IV
•Chronic kidney disease CKD IIIb-IV, end-stage renal disease
•Acute or chronic liver failure
•Clinically significant gastroparesis
•Active malignancy
•Haemoglobin < 100 g/l
•Pregnancy, breast-feeding, or in case of women with child-bearing potential willingness to be pregnant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method