A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycemic Efficacy and Renal Safety of Dapagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inadequate Glycemic Control.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
研究概览
简要总结
The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.
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
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged ≥18 years and <75 years.
- •History of T2DM for more than 12 months.
- •Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%
- •Stable anti-diabetic treatment regimen
- •Renal impairment: CKD 3A
排除标准
- •Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
- •History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- •Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg
- •Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:
- •Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.
- •History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
- •Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
- •Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening.
- •Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.
研究组 & 干预措施
Dapagliflozin
10 mg Tablets, Oral, Once daily, 24 weeks
干预措施: Dapagliflozin 10 mg (Drug)
Placebo
Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks
干预措施: Matching Placebo for Dapagliflozin (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
时间窗: Baseline, Week 24
To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.
次要结局
- Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.(Baseline, Week 24)
- Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.(Baseline, Week 24)
- Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.(Baseline, Week 24)