EUCTR2015-005041-31-GB进行中（未招募）1 期
A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial with a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients aged 10-24 years
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Provision of informed consent prior to any study-specific procedures
- •- Males and Females, ages 10 years of age, up to but not including 25 years of age at the time of randomization
- •- Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria
- •- HbA1c >= 6.5% and <= 11% obtained at screening visit
- •- Currently on diet and exercise and a stable dose of metformin (at least 1000 mg daily) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of metformin (at least 1000 mg daily) and insulin for a minimum of 8 weeks prior to screening
- •- FPG <= 255 mg/dL (<= 14.2 mmol/L) obtained at screening visit
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 21
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous diagnosis of Type 1 diabetes
- •- Diabetes ketoacidosis (DKA) within 6 months of screening
- •- Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
- •*Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics or other antidiabetes medications not otherwise specified
- •* Sixteen weeks: thiazolidinediones
- •* Any previous history or current use of an SGLT2 inhibitor, including dapagliflozin
- •- Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening. Use of prescription or non-prescription weight loss drugs must be stable
- •during the study
- •- Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
- •- History of unstable or rapidly progressive renal disease
- •-History of unresolved vesico-ureteral reflux
- •- Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit
- •Note: Topical, nasal, or inhaled corticosteroids are allowed
- •- Abnormal renal function, which is defined in subjects < 18 years of age as an estimated glomerular filtration rate (eGFR) calculated by the Schwartz Formula < 80 mL/min/1.73 m2
- •(1.33 mL/s), and in subjects >= 18 years as an estimated glomerular filtration rate (eGFR) calculated by the MDRD Formula < 60 mL/min/1.73 m2 (1.33 mL/s)
- •- Presence of either: antibodies to glutamic acid decarboxylase (GAD) or protein tyrosine phosphatase-like protein antibodies (IA-2)
- •- An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded
- •- Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization
- •- Anemia of any etiology defined as hemoglobin <= 10.7 g/dL (107 g/L) for females and <= 11.3 g/dL (113 g/L) for males. Subjects who are considered to have anemia according to local guidelines should be excluded
- •- Volume-depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics, should carefully monitor their volume status
研究者
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