NCT02268214已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus
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
- 833
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change in HbA1c From Baseline at Week 24
研究概览
简要总结
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.
详细描述
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 1 Diabetes mellitus (T1DM)
- •Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)
- •Insulin use for at least 12 months per patient reported or medical records
- •Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening
- •Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to screening
- •If on MDI insulin administration, subject must be on ≥ 3x injections per day
- •Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%
- •Body mass index (BMI) ≥ 18.5 kg/m2
排除标准
- •History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity
- •Taking metformin and/or thiazolidinediones within 2 months prior to screening
- •Taking any antidiabetic medication (other than insulin), within 1 month prior to screening
- •Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration
- •History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening
- •History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening
- •Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening
- •History of Addison's disease
研究组 & 干预措施
Arm A: Dapagliflozin
Experimental
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
干预措施: Dapagliflozin (Drug)
Arm B: Dapagliflozin
Experimental
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
干预措施: Dapagliflozin (Drug)
Arm C: Placebo for Dapagliflozin
Placebo Comparator
Placebo tablet orally, once daily for 52 weeks
干预措施: Placebo for dapagliflozin (Drug)
结局指标
主要结局
Adjusted Mean Change in HbA1c From Baseline at Week 24
时间窗: From Baseline to Week 24
Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model\[RMM\]).
次要结局
- Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24(From Baseline to Week 24)
- Adjusted Mean Percent Change in Body Weight From Baseline at Week 24(From Baseline to Week 24)
- Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24(From Baseline to Week 24)
- Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24(From Baseline to Week 24)
- Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24(From Baseline to Week 24)
- Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events(From Baseline to Week 24)
研究者
研究点 (1)
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