Type 2 diabetes mellitus MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Insulina basale/GLP-1RA in rapporto fisso
Product Code: [IGlarLixi]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 00166201
CAS Number: 160337-95-1
Current Sponsor code
Sponsors
A.O.U. Università degli Studi della Campania "Luigi Vanvitelli"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients on insulin therapy basal bolus stable for at least one year associated or not with metformin • Insufficient glycemic control (HbA1c> 7.5% 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: • Type 1 diabetes or diabetes secondary to specific causes • Previous treatment (within the last 3 months) with a GLP-1RA or a DPPIV inhibitor • Contraindications to the use of GLP-1RA (pancreatitis, gallbladder stones) • Pregnancy or pregnancy scheduled during the study period • Serum creatinine> 1.3 mg / dL in women and> 1.4 mg / dL in men • GFR <30 ml / min • History of cancer or anti-neoplastic therapy in the 5 years prior to randomization • Current therapy with oral, topical or systemic glucocorticoids, or with atypical anti-psychotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine whether the basal insulin / GLP-1RA combination therapy in fixed ratio or basal insulin / SGLT2-i results in a better durability of the glycemic control compared to the insulin basal bolus regimen in patients with non-target type 2 diabetes with multi-insulin regimen injecting.;Secondary Objective: Evaluate the effects of basal / GLP-1RA insulin combination therapy in fixed ratio or basal insulin / SGLT2-i on clinical indicators of glyco-metabolic control compared to the insulin basal bolus regimen in patients with non-target type 2 diabetes with multi insulin regimen -iniettivo. Specifically, the variations of the main clinical outcomes will be measured: 1. glycemic control parameters (fasting blood glucose - FPG - and post-prandial - PPG) 2. lipid structure (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) 3. body weight and body mass index (BMI) 4. waist circumference (CV) 5. arterial pressure (PA) 6. Glomerular filtration rate (GFR) The following changes will also be evaluated: 1. C-peptide 2. Insulin doses 3. Diabetes Treatment Questionnaire (DTSQ);Primary end point(s): Durability of glycemic control intended as: • persistent HbA1c variability of 30% during follow-up • proportion of patients experiencing an improvement in HbA1c as a reduction =0.5% compared to the levels measured at baseline during follow-up;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Variation of: • body weight and BMI • waist circumference • blood pressure • fasting blood sugar • post-prandial blood glucose • C-peptide • daily insulin doses • lipid structure (total cholesterol, LDL- and HDL-cholesterol and triglycerides) • glomerular filtration rate (GFR) • anti-diabetes treatment satisfaction (DTSQ);Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactU.O.C. di Endocrinologia e Malattie
A.O.U. Università degli studi della Campania "L. Vanvitelli"
Outcome results
None listed