type 2 diabetes
Conditions
Interventions
Trade Name: Galvus
Pharmaceutical Form: Tablet
Trade Name: Amaryl
Pharmaceutical Form: Tablet
Sponsors
AFAR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age between 40 and 80 years - Both sexes - Treated with metformin and basal insulin - With HbA1c between 7-9% 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Type 1 diabetes; - Chronic systemic diseases, immunologic, neoplastic; - Cardiovascular, renal and hepatic - AST, ALT 2 times higher than the reference values - Women who are pregnant or intend to become pregnant - Breastfeeding women. - Drug therapy can interfere with glucose metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the effects of the addition of vildagliptin or glimepiride, in patients in failure with basal insulin and Metformin, on the time (in minutes / day) spent in euglycemia (70-140 mg / dl);Secondary Objective: Secondary objectives: assessment of intra-glycemic variability, on postprandial blood glucose, the total glycemic load, indices of oxidative stress and some surrogate parameters of cardiovascular risk;Primary end point(s): time (in minutes / day) spent in euglycemia (70-140 mg / dl);Timepoint(s) of evaluation of this end point: At 0-12-24 and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): effects on indices intraday glycemic variability, postprandial blood glucose, total glycemic load, indices of oxidative stress and some surrogate parameters of cardiovascular risk;Timepoint(s) of evaluation of this end point: At 0-12-24 and 52 weeks | — |
Countries
Italy
Contacts
Public ContactUO Endocrinology
AFAR
Outcome results
None listed