Impact of treatment with Dapagliflozin in type 1 diabetic patients

Conditions: Type 1 diabetes
MedDRA version: 18.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2015-002963-40-ES

Lead Sponsor: Dra Cristina Avendaño Sola

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1)Women or men aged 18-55 years od oldf at the time of completion of the informed consent.
(2)Written informed consent in conformity with local legislation obtaines before the performance of any procedure.
(3)Patients with a diagnosis of type 1 diabetes mellitus (Diabetes diagnosed before 30 years old in a patient without overweight/obesity or diabetes diagnosed before 45 years old with evidence of positive pancreatic autoantibodies)
(4)Treatment with multiple daily dose of insulin (1-2 injections of Glargina/Detemir with 3 injections of rapid insulin analogues) or continous subcutaneous insulin infusion therapy
(5)HbA1c greater than 7% in at least two consecutive blood tests (separated at least for 3 months) performed during the past 6 months previous to the beginning of the study
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 57
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(1)Inability to give inform consent in the absence of a legal guardian
(2)Pregnancy or lactation
(3)If there are any clijnical, biochemical, cognitive, social or psycosocial factors (considered by the investigador) that could negative influence the study or patient.
(4)Liver disease (history of chronic liver disease or alteration in liver function tests: AST, ALT, bilirrubin, GGT)
(5)Renal failure (MDRD < 60 ml/min)
(6)History of multiple urinary tract or mycotic genital infections
(7)History of baldder cancer
(8)History of electrolyte disorders (SIADH, insipid diabetes, hyponatremia)
(9)Treatment with loop diuretics
(10)Haven received any drug under investigation, including antivirals, during the previous 6 months of starting the study.