JPRN-jRCT2080223107UnknownPhase 3
A Clinical Pharmacology and Long Term Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With Type 1 Diabetes Who Have Inadequate Glycemic Control
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- AstraZeneca
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- ot applicable to ot applicable (—)
- Sex
- All
Inclusion 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
- •- Insulin use for at least 12 months prior to the enrolment per subject report or medical records and Method of insulin administration (MDI or CSII) 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. If on 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 7.5% or more and 10.5% 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 20.0% kg/m2 or more at visit 1
- •- Age 18 to 75 years, inclusive
- •18 years old or more and < 20 years old must have assent forms signed and dated by their parents or guardians
Exclusion Criteria
- •- Target Disease Exceptions History of Type 2 diabetes mellitus (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 laboratory, 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 anti-hyperglycemic agent use, other than Alpha-GI or insulin, within 1 month prior to the enrolment. Alpha-GI users at the enrolment or within 1 month prior to the enrolment are permitted to enter this study, if subjects can conduct wash-out of the drug.
- •Use of thiazolidinediones within 6 months prior to the enrolment
- •- History of Diabetic Ketoacidosis (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
- •- 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 45mL/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
Investigators
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