EUCTR2015-002963-40-ES
Active, Not Recruiting
N/A
Impact of treatment with Dapagliflozin (SGLT2 inhibitor) in metabolic control and glycemic pattern in type 1 diabetic patients - IDAPADM1
Dra Cristina Avendaño Sola0 sitesJuly 31, 2015
DrugsForxiga 10 mg
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dra Cristina Avendaño Sola
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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