type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Jardiance 10 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/ALU)- 28 COMPRESSE
Product Name: empaglifozin
Product Code: na
Pharmaceutical Form: Film-coated tablet
INN or Propose
Sponsors
Azienda Ospedaliero-Universitaria di Parma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age 35-75 years diagnosis of type 2 diabetes ( 0.3 nmol/l; GAD-antibody negative 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 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: diagnosis of type 1 diabetes history of cancer in the previous 5 years acute cardiovascular event within the previous 6 months multiple daily insulin treatment chronic heart failure eGFR < 45 ml.min-1.1.73 m2 women of child bearing potential with no use of acceptable contraception presence of diabetic retinopathy contraindications to the use of any drug of POLYCHEM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the T2DM 12-month remission rate in patients with newly diagnosed T2DM treated with either POLYCHEM (Metformin, pioglitazone, sitagliptin and empagliflozin) or Standard of diabetes care (SDC);Secondary Objective: -to assess if the proportion of complete remission of T2DM after 52 weeks is different in POLYCHEM respect to SDC (complete remission is defines as all values of fasting glucose, 2-hour glucose and HbA1c are within the limits of normal glucose) -to assess if the time of remission of hyperglicemia is different in POLYCHEM respect to SDC -to monitor the costs of National Health System service utilization and the quality of life (QoL) during 1 year in the 2 groups. -to quantify the effects of either POLYCHEM or SDC on the main determinants of glucose regulation (beta, alpha, K and L cell function; insulin sensitivity; glycosuria; absorption/appearance of oral glucose; splanchnic glucose extraction) ;Primary end point(s): Proportion of complete remission after 52 weeks of treatment in the 2 arms. The primary end point will be assessed through adaptive design. For the POLYCHEM-ARM, Minimax two-stage Simon design will be used, with early termination at stage 1, if T2DM remission at 3-month follow-up falls below a predefined threshold. The analysis at stage 1 will be performed when 48 patients of POLYCHEM-ARM will reach 3-month follow-up (V2B), and, if remissions<8, randomization to POLYCHEM-ARM will be stopped (but continued in the SDC-ARM) at the 8th month of enrolment, i.e. with about 80 randomized patients. In this case, the sample will be resized with a 2:1 ratio (160 in SDC-ARM, 80 in POLYCHEM-ARM), with a further widening in the C.I. of the difference in remission rate at 12 months of 4 percentage points.;Timepoint(s) of evaluation of this end point: after 52 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -proportion of complete T2DM remission in the 2 groups -proportion of recurrences of T2DM and time to relapse in the 2 groups -comparison of costs of National Health System service utilization in the 2 groups -comparison of the quality of life (EQ-5D and ADDQoL ) in the 2 groups -comparison of insulin sensitivity and beta cell function measured either by gold standard techniques or by surrogate index in the 2 groups -comparison of the main determinants of glucose regulation (beta, alpha, K and L cell function; insulin sensitivity; glycosuria; absorption/appearance of oral glucose; splanchnic glucose extraction) in the 2 groups ;Timepoint(s) of evaluation of this end point: after 52 weeks of treatment | — |
Countries
Italy
Contacts
Public ContactUOC endocrinologia
Azienda Ospedaliero-Universitaria di Parma
Outcome results
None listed