Proof of concept study, a randomized, controlled, open and prospective period of one year to evaluate the effectiveness of treatment with saxagliptin / dapagliflozin + metformin vs insulin glargine + metformin in patients with Autoimmune Diabetes of the Adult (LADA) - Proof of concept study on LADA

IVERSITÀ CAMPUS BIO-MEDICO DI ROMA0 个研究点目标入组 100 人开始时间: 2021年6月8日最近更新: 2021年8月24日

适应症

试验速览

暂无简介。

•1.Provision of informed consent prior to any study specific procedures
•2.Female and Male subjects aged >18 years and < 75 years
•3.Previous diagnosis of diabetes
•4.Duration of diabetes at entry >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

•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 <0.6ng/ml
•4.Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) = 1.5 mg/dL in males or = 1.4 mg/dL in females
•5.Alanine aminotransferase and/or aspartate aminotransferase levels >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

发起方

IVERSITÀ CAMPUS BIO-MEDICO DI ROMA