Type 1 diabetes MedDRA version: 18.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Forxiga 10 mg
Product Name: Dapagliflozine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dapagliflozine
CAS Number: 461432-26-8
Current Sponsor code: Forxiga
Other descripti
Sponsors
Dra Cristina Avendaño Sola
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the antidiabetic efficacy at short term, measured by HbA1c, of treatment with dapagliflozine in type 1 diabetic patients;Secondary Objective: (1)Evaluate the efficacy of dapagliflozine in terms of: *Ambulatory glucose profiles *Clinical and anthropometrics parameters *Biochemichal parameters (2)Evaluate safety of the treatment (3)Evaluate the grade of satisfaction of the antidiabetic treatment;Primary end point(s): Mean value of HbA1c assessed at baseline and at the end of the 12 weeks of treatment with dapagliflozin;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1)Mean value of HbA1c assessed at the end of treatment and at the end of follow-up period (2)Assessment of other variables related to metabolic control: a) Mean value of the following variables assessed at baseline and at the end of treatment and follow-up periods: fasting venous glucose, glucose in urine, dose of insulin (daily dose of prandial insulin, daily dose of basal insulin, total daily dose of insulin b)Mean value of the following parameters measured during continuous glucose monitoring periods: *Mean value of ambulatory glucose profiles *Glycemic exposure: area under the curve (mmol/L/hour) *Number of hypoglycemias (more tha 10 minutes under 70 mg/dL) *Percentage of time in the following glycemic ranges (mg/dL): 180; >250 (3) Mean value of the following parameters related to glycemic variability measured during baseline (before treatment), during the first 6 days of treatment and during the last 6 days of treatment: a) SD: standard deviation (mg/dL) b)Coefficient of variation c)MAGE (mean amplitude of glycemic excursion) d)HBGI (high blood glucose index) e)LBGI (low blood glucose index) (4) Mean of the following clinical parameters assessed at baseline and at the end of treatment and follow-up periods: weight, abdominal circumference, BMI, body composition, systolis and diastolic blood pressure, heart rate (5) Mean of the following biochemical parameters assessed at baseline and at the end of treatment and follow-up periods: uric acid and C reactive protein (6) Safety and tolerance: assessed at baseline, at the end of treatment and in any required clinical situation: a)Physical examination b)Vital signs c)Laboratory tests: renal and hepatic profile, lipids, electrolytes and urynalisis d)Measurement of ketone bodies in plasma (this would be measured additionally every 15 days during the treatment period) and urine e)Report of adverse effects: laboratory | — |
Countries
Spain
Contacts
Public ContactMaria Belen Ruiz Antoran
Hospital Puerta de Hierro
Outcome results
None listed