Diabetes Mellitus type II
Conditions
Interventions
Trade Name: Forgixa
Pharmaceutical Form:
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Franciscus Gasthuis
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - 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% - =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Current smoking - Impaired renal function (MDRD 20 mmol/l requiring hospital admittance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands
Contacts
Public ContactB. Burggraaf
Franciscus Gasthuis
Outcome results
None listed