JPRN-jRCT2080223106未知1 期
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
适应症
试验速览
- 阶段
- 1 期
- 发起方
- AstraZeneca
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •- 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
研究者
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