Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise
2022年4月21日 更新者：Sanofi
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin as Monotherapy in Chinese Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise
Primary Objective:
To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise.
Secondary Objectives:
- To compare sotagliflozin dose 1 versus placebo for change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT), change in fasting plasma glucose (FPG), and change in body weight.
- To compare sotagliflozin dose 2 versus placebo for change in HbA1c, change in 2-hour PPG following a MMTT, change in FPG, and change in body weight.
- To compare sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo for change in systolic blood pressure (SBP) for all patients, and change in SBP for patients with baseline SBP ≥130 mmHg.
- To evaluate the safety of sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo.
研究概览
详细说明
Total study duration is up to 30 weeks, including a screening period consisting of a screening phase of up to 2 weeks and a 2-week single-blind placebo run-in phase, a 24-week double-blind treatment period, and a 2-week post-treatment follow-up visit period to collect safety information.
研究类型
介入性
注册 (实际的)
276
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing、中国、100044
- Investigational Site Number 1560001
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Beijing、中国、100730
- Investigational Site Number 1560003
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Beijing、中国、100730
- Investigational Site Number 1560004
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Beijing、中国、101200
- Investigational Site Number 1560002
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Changchun、中国、130021
- Investigational Site Number 1560007
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Changchun、中国、130041
- Investigational Site Number 1560008
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Chongqing、中国、400010
- Investigational Site Number 1560024
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Guangzhou、中国、510120
- Investigational Site Number 1560022
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Guangzhou、中国、510150
- Investigational Site Number 1560033
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Guangzhou、中国
- Investigational Site Number 1560021
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Harbin、中国、150001
- Investigational Site Number 1560029
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Hohhot、中国、010017
- Investigational Site Number 1560009
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Huai'An、中国、223300
- Investigational Site Number 1560014
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Huzhou、中国
- Investigational Site Number 1560019
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Jining、中国
- Investigational Site Number 1560025
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Jining、中国
- Investigational Site Number 1560027
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Luoyang、中国
- Investigational Site Number 1560012
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Pingxiang、中国、337055
- Investigational Site Number 1560013
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Qingdao、中国、266011
- Investigational Site Number 1560034
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Qingdao、中国、266042
- Investigational Site Number 1560026
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Shanghai、中国、200040
- Investigational Site Number 1560017
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Shanghai、中国
- Investigational Site Number 1560016
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Shijiazhuang、中国
- Investigational Site Number 1560006
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Tianjin、中国、300211
- Investigational Site Number 1560005
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Wuhan、中国、430000
- Investigational Site Number 1560035
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Xuzhou、中国、221006
- Investigational Site Number 1560023
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Yinchuan、中国、750004
- Investigational Site Number 1560028
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Yuncheng、中国、044000
- Investigational Site Number 1560032
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Zhuzhou、中国、412007
- Investigational Site Number 1560015
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria :
- Chinese patients with Type 2 Diabetes who are treated with diet and exercise only during the 12 weeks prior to screening
- Signed written informed consent.
Exclusion criteria:
- Age <18 years at the screening visit.
- Type 1 diabetes.
- Hemoglobin A1c <7% or >10% measured by the central laboratory at the screening visit.
- Fasting plasma glucose >15 mmol/L (>270 mg/dL) measured by the central laboratory at the screening visit and confirmed by a repeat test (>15 mmol/L [>270 mg/dL]) before randomization
- Body mass index (BMI) ≤20 or >45 kg/m² at the screening visit.
- Women of childbearing potential not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
- Previous use of any antidiabetic medication(s) for >4 months at any time or previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes).
- Previous use of any antidiabetic drug within 12 weeks prior to the screening visit.
- History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the screening visit.
- History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar coma within 12 weeks prior to the screening visit.
- Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (diastolic blood pressure (DBP)).
- History of hypertensive emergency within 12 weeks prior to the screening visit.
- Patients with severe anemia, severe cardiovascular (CV) (including congestive heart failure New York Heart Association (NYHA) IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal (ULN) laboratory range.
- Total bilirubin >1.5 times the ULN (except in case of Gilbert's syndrome).
- Use of systemic glucocorticoids (excluding topical or ophthalmic application, nasal spray, or inhaled forms) for more than 10 consecutive days within 90 days prior to the screening visit.
- Patient who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives prior to the screening visit, whichever is longer.
- Pregnant (confirmed by serum pregnancy test at the screening visit) or breastfeeding women.
- Patients with severe renal disease as defined by an eGFR of <30 mL/min/1.73m² at the screening visit, based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation.
- Patient unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the patient diary, or comply with study visits and other study procedures as required per protocol.
- Patients unable to consume at least 50% of the standard meal during the MMTT at baseline (Day 1, Visit 3) before randomization.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sotagliflozin 剂量 1
Sotagliflozin 剂量 1，分为两 (2) 剂，每次 2 片，每天一次，在当天的第一餐前服用
|
药物剂型：片剂 给药途径：口服 |
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实验性的：Sotagliflozin 剂量 2
Sotagliflozin 剂量 2，作为 1 片 sotagliflozin 剂量 2 片剂和 1 片 sotagliflozin 匹配的安慰剂片剂（在外观上与 sotagliflozin 剂量 2 相同），每天一次，在当天的第一顿饭前
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药物剂型：片剂 给药途径：口服 药物剂型：片剂 给药途径：口服 |
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安慰剂比较：安慰剂
两片 sotagliflozin 匹配安慰剂片（外观与 sotagliflozin 剂量 2 相同），每天一次，在当天的第一餐前
|
药物剂型：片剂 给药途径：口服 |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in hemoglobin A1c (HbA1c)
大体时间：Baseline to Week 24
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Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose1)
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Baseline to Week 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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混合膳食耐受性测试 (MMTT) 后 2 小时餐后血糖 (PPG) 的变化
大体时间：第 24 周的基线
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MMTT 后 2 小时 PPG 从基线到第 24 周的绝对变化（对于 sotagliflozin 剂量 1 和 2）
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第 24 周的基线
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体重变化
大体时间：第 24 周的基线
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体重从基线到第 24 周的绝对变化（sotagliflozin 剂量 1 和 2）
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第 24 周的基线
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HbA1c 的变化
大体时间：第 24 周的基线
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HbA1c 从基线到第 24 周的绝对变化（sotagliflozin 第 2 剂）
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第 24 周的基线
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不良事件
大体时间：直到第 24 周
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发生不良事件的患者人数
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直到第 24 周
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Change in fasting plasma glucose (FPG)
大体时间：Baseline to Week 24
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Absolute change from baseline to week 24 in FPG (for sotagliflozin dose1 and 2)
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Baseline to Week 24
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Change in systolic blood pressure (SBP) for all patients
大体时间：Baseline to Week 12
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Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose1 and 2)
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Baseline to Week 12
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Change in SBP for patients with baseline SBP ≥130 mmHg
大体时间：Baseline to Week 12
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Absolute change from baseline to week 12 in SBP patients with baseline SBP ≥130 mmHg (for sotagliflozin dose1 and 2)
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Baseline to Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年11月27日
初级完成 (实际的)
2020年4月24日
研究完成 (实际的)
2020年4月24日
研究注册日期
首次提交
2018年11月29日
首先提交符合 QC 标准的
2018年11月29日
首次发布 (实际的)
2018年12月3日
研究记录更新
最后更新发布 (实际的)
2022年4月25日
上次提交的符合 QC 标准的更新
2022年4月21日
最后验证
2022年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- EFC15194
- U1111-1195-6181 (其他标识符：UTN)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.