Influence of a new diabetesmedicine on cholesterol and other factors after intake of a fatty meal in patients with diabetes
- Conditions
- Diabetes Mellitus type IITherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-001417-24-NL
- Lead Sponsor
- Franciscus Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
- Age of 18 years of older;
- Male
- Diabetes mellitus type 2 on intensive insulin treatment (three times short acting and once daily long acting) (unchanged for > 10 weeks prior to consent)
- Stable glucose regulation last 6 months (HbA1c > 6.5% - < 9.0%)
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Current smoking
- Impaired renal function (MDRD <60 ml/min/1.73 m2)
- Recent use of SGLT-2 inhibitor (past 6 months)
- Recent cardiovascular event (past 6 months) (myocardial infarction, coronary artery bypass grafting, stroke)
- Severe hyperglycemic events in the past 6 months (hyperglycemia >20 mmol/l requiring hospital admittance)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Effect of dapagliflozin on postprandial leukocyte activation markers (CD35, Cd11b and CD66b);Timepoint(s) of evaluation of this end point: At end of study (after 12 weeks of treatment).;Main Objective: To explore the effects of dapagliflozin compared with placebo on postprandial leukocyte activation markers in men with type 2 diabetes mellitus.;Secondary Objective: To explore the effect of a dapagliflozin compared with placebo on postprandial lipemia, oxidative stress and endothelial function in men with type 2 diabetes mellitus
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Effect of dapagliflozin on postprandial lipemia, oxidative stress and vascular function.;Timepoint(s) of evaluation of this end point: At end of study (after 12 weeks of treatment).