NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 1 Diabetes Mellitus
Date of first enrollment	18/02/2016
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Dapagliflozin 5mg, Dapagliflozin 10mg INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Dapagliflozin 5mg: Dapagliflozin, a blood glucose lowering drug. Oral dose, Dapagliflozin 10mg: Dapagliflozin, a blood glucose lowering drug. Oral dose control material(s) Generic name etc : Placebo tablet INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo tablet: Oral dose

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	- Signed Written Informed Consent Subjects or their legally responsible representatives must be willing and able to give signed and dated written informed consent. - Target Population Diagnosis of T1DM. In addition, the following criteria also needs to be met; Central laboratory test of C-peptide < 0.7ng/mL Subject re-enrolment: This study does not permit the re-enrolment of a subject who has discontinued the study as a screen failure - Insulin use for at least 12 months prior to the enrolment per subject report or medical records and Method of insulin administration (MDI) must have been unchanged for at least 3 months prior to the enrolment per subject report or medical records. Subjects must be taking a total daily insulin dose of 0.3U/kg/day or more for at least 3 months prior to the enrolment. CSII users are excluded. MDI insulin administration subject must be on 3x injections per day or more. - Gender and reproductive Status Japanese men and women. - HbA1c eligibility criteria include: Screening Visit: Central laboratory HbA1c 7.0% or more and 10.0% or less (One repeat HbA1c test for subjects in screening if their initial test result was an HbA1c +- 0.2% of the cut off values) - BMI 20.0kg/m2 or more, 35.0kg/m2 or less at visit 1 - Ages 18 to 65 years, inclusive - 18 years old or more and < 20 years old must have assent forms signed and dated by their parents or guardians
Exclude criteria	- Target Disease Exceptions History of T2DM In cases where the subject has a history of T2DM and has a documented history of being auto-antibody positive for GAD65, tyrosine phosphatase IA-2/IA-2 Beta, or Zinc Transporter 8 (ZnT8), or fasting c-peptide value below the lower limit of detection performed by local or central laborator, the subject will be eligible for screening - Maturity onset diabetes of young (MODY), Pancreatic surgery, chronic pancreatitis, or other pancreatic disorders that could result in decreased Beta-cell capacity (eg, pancreatogenous diabetes) - Any antihyperglycemic agent use, other than thiazolidinediones, or insulin, within 1 month prior to the screening visit. Use of thiazolidinediones within 6 months prior to the screening visit. - History of DKA requiring medical intervention (eg, emergency room visit and/or hospitalization) within 1 month prior to the enrolment - History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to the enrolment - Malignancy within 5 years of the enrolment (with the exception of treated basal cell or treated squamous cell carcinoma) - History of bladder cancer - History of radiation therapy to the lower abdomen or pelvis at any time Unstable pre-proliferative and proliferative retinopathy (untreated or under treatment). - Physical and Laboratory Test Findings Aspartate aminotransferase (AST) > 3x upper limit of normal (ULN) Alanine aminotransferase (ALT) > 3x ULN Serum total bilirubin (TB) > 2.0mg/dL (34.2 micro mol/L). - Estimated GFR (eGFR) by the Japanese Society of Nephrology formula 60 mL/min/1.73m2 or less. Hemoglobin 11.0g/dL(110g/L) or less for men; hemoglobin 10.0g/dL(100g/L) or less for women. - Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody - Abnormal Free T4