NCT02725593已完成3 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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24
研究概览
简要总结
A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
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, 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 T
- •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
研究组 & 干预措施
Dapagliflozin
Experimental
干预措施: Dapagliflozin (Drug)
Dapagliflozin placebo
Placebo Comparator
干预措施: Dapagliflozin placebo (Drug)
结局指标
主要结局
Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24
时间窗: Baseline to Week 24
次要结局
- Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24(Baseline to Week 24)
- Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control(Baseline to Week 24)
- Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24(Baseline to Week 24)
研究者
研究点 (1)
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