LADA MedDRA version: 21.0 Level: PT Classification code 10066389 Term: Latent autoimmune diabetes in adults System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: ONGLYZA - 5 MG-COMPRESSE RIVESTITE CON FILM -USO ORALE-BLISTER NON PERFORATO(ALU/ALU) 28 COMPRESSE
Product Name: ONGLYZA
Product Code: 039453016
Pharmaceutical Form: Film-coated tablet
Tr
Sponsors
UNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female and Male subjects aged >18 years and 6 months 5. Positivity for GAD antibodies 6. Treatment with any anti-diabetic drug but insulin at the time of entry into the trial. 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Insulin therapy at diagnosis of diabetes. Subjects on saxagliptin and on dapagliflozin will be included in the study. As for study protocol (see section 5.3.2) saxagliptin and daplagliflozin will be suspended before randomization. 2. Weight loss >20% of body weight within the previous six months 3. Baseline C-peptide 2 x ULN 6. History of malignancy (including bladder neoplasia), psychiatric disorders and substance abuse 7. History diabetic ketoacidosis 8. Concomitant use of corticosteroids and/or concomitant use of loop diuretics 9. Evidence of sever diabetes-related complications interfering, in the opinion of the investigator, with the participation of subjects in the trial. 10. Pregnancy 11. Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the combination saxagliptin/dapagliflozin + metformin is non-inferior to treatment with metformin + insulin glargine in terms to improveof ¿ -cell function in patients with LADA;Secondary Objective: To evaluate if the combination saxagliptin/dapagliflozin + metformin is associated with a better metabolic control (measured by HbA1c), improved insulin sensitivity (measured by HOMA-IR index), lower number of self-reported hypoglycaemic events and a reduction of body weight, as compared with the association metformin + insulin Assess whether the combination of saxagliptin / dapagliflozin plus metformin than with the insulin + metformin is associated with a better metabolic control (HbA1c evaluation), improved insulin sensitivity (as measured by the HOMA-IR), the lowest number hypoglycemic events and weight reduction.;Primary end point(s): Change in the area under the curve (AUC) of C-peptide after running a MMTT in patients treated for one year with saxagliptin / dapagliflozin plus metformin vs patients treated with insulin glargine + metformin;Timepoint(s) of evaluation of this end point: 6 months after beginning treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HbA1c, number hypoglycemic events (blood glucose <70 mg / dl), HOMA-IR index and weight loss in patients treated for one year with saxagliptin / dapagliflozin plus metformin vs patients treated with insulin glargine + metformin;Timepoint(s) of evaluation of this end point: end of trial | — |
Countries
Italy
Contacts
Public ContactEndocrinologia e diabetologia
Universit¿ Campus Bio-Medico di Roma
Outcome results
None listed