A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
2018年7月20日 更新者：Merck Sharp & Dohme LLC
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy, Alone or in Combination With Metformin
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM).
The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.
研究概览
研究类型
介入性
注册 (实际的)
498
阶段
- 第三阶段
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 至 79年 (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:
- has T2DM
- is currently on a stable regimen of gliclazide or glimepiride, either alone or in combination with metformin for ≥ 10 weeks
- has a Visit 1/Screening HbA1C between 7.5% and 11.0%
- is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication
Exclusion Criteria:
- has a history of type 1 diabetes mellitus or a history of ketoacidosis
- has been treated with any antihyperglycemic therapies other than a sulfonylurea (alone or with metformin) within the prior 12 weeks or has ever
been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue
- has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, gliclazide/glimepiride, or metformin
- is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months
- has undergone a surgical procedure within 4 weeks or has planned major surgery during the study
- has a medical history of active liver disease
- has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder
- has a diagnosis of congestive heart failure with New York Heart Association Class III - IV cardiac status
- has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg
- has human immunodeficiency virus (HIV)
- has severe peripheral vascular disease
- is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
- has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- has a clinically important hematological disorder (such as aplastic anemia,
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication
- is a user of recreational or illicit drugs or has had a recent history of drug abuse
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sitagliptin
Sitagliptin 100 mg once daily for 24 weeks.
Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
All participants will receive placebo during run-in period.
|
Sitagliptin 100 mg oral tablet once daily for 24 weeks
其他名称：
Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.
Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.
Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.
|
|
安慰剂比较：Placebo
Matching placebo once daily for 24 weeks.
Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
|
Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.
Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.
Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.
Matching placebo to sitagliptin oral tablet once daily for 24 weeks
|
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 |
|---|---|---|
|
Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
大体时间：Baseline and Week 24
|
A1C was measured as a percent.
This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
|
Baseline and Week 24
|
|
Number of Participants Who Experienced an Adverse Event
大体时间：Up to 26 weeks
|
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment.
Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
|
Up to 26 weeks
|
|
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
大体时间：Up to 24 weeks
|
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment.
Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
|
Up to 24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
大体时间：Baseline and Week 24
|
This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
|
Baseline and Week 24
|
|
Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
大体时间：Baseline and Week 24
|
This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
|
Baseline and Week 24
|
|
Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin
大体时间：Baseline and Week 24
|
A1C was measured as a percent.
This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
|
Baseline and Week 24
|
|
Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
大体时间：Baseline and Week 24
|
A1C was measured as a percent.
This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
|
Baseline and Week 24
|
|
Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin
大体时间：Baseline and Week 24
|
This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
|
Baseline and Week 24
|
|
Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
大体时间：Baseline and Week 24
|
This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
|
Baseline and Week 24
|
|
Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin
大体时间：Baseline and Week 24
|
This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
|
Baseline and Week 24
|
|
Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
大体时间：Baseline and Week 24
|
This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
|
Baseline and Week 24
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2012年7月9日
初级完成 (实际的)
2014年6月10日
研究完成 (实际的)
2014年6月24日
研究注册日期
首次提交
2012年5月1日
首先提交符合 QC 标准的
2012年5月2日
首次发布 (估计)
2012年5月3日
研究记录更新
最后更新发布 (实际的)
2018年8月17日
上次提交的符合 QC 标准的更新
2018年7月20日
最后验证
2018年7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
- 0431-253
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
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
研究数据/文件
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.