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A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

2015年9月30日 更新者：AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

915

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2R 0X7
        • Local Institution
    • British Columbia
      • Kelowna、British Columbia、加拿大、V1Y 2H4
        • Local Institution
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3E 3P4
        • Local Institution
    • New Brunswick
      • Bathurst、New Brunswick、加拿大、E2A 4X7
        • Local Institution
    • Newfoundland and Labrador
      • Mount Pearl、Newfoundland and Labrador、加拿大、A1N 1W7
        • Local Institution
      • St-John、Newfoundland and Labrador、加拿大、A1E 2E2
        • Local Institution
    • Ontario
      • Sarnia、Ontario、加拿大、N7T 4X3
        • Local Institution
      • Thornhill、Ontario、加拿大、L4J 8L7
        • Local Institution
      • Toronto、Ontario、加拿大、M4R 2G4
        • Local Institution
      • Toronto、Ontario、加拿大、M9W 4L6
        • Local Institution
    • Prince Edward Island
      • Charlottetown、Prince Edward Island、加拿大、C1A 5Y9
        • Local Institution
    • Quebec
      • Drummondville、Quebec、加拿大、J2B 7T1
        • Local Institution
      • Granby、Quebec、加拿大、J2G 8Z9
        • Local Institution
      • L'Ancienne Lorette、Quebec、加拿大、G2E 2X1
        • Local Institution
      • Mirabel、Quebec、加拿大、J7J 2K8
        • Local Institution
      • St-Leonard、Quebec、加拿大、H1S 3A9
        • Local Institution
    • Saskatchewan
      • Saskatoon、Saskatchewan、加拿大、S7K 3H3
        • Local Institution
      • Saskatoon、Saskatchewan、加拿大、S7K 7H9
        • Local Institution
  • 墨西哥
      • Durango、墨西哥、64710
        • Local Institution
    • Distrito Federal
      • Df、Distrito Federal、墨西哥、11800
        • Local Institution
      • Guadalajara、Distrito Federal、墨西哥、44670
        • Local Institution
      • Zapopan、Distrito Federal、墨西哥、45150
        • Local Institution
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44650
        • Local Institution
      • Guadalajara、Jalisco、墨西哥、44670
        • Local Institution
    • Nuevo Leon
      • Monterrey、Nuevo Leon、墨西哥、64710
        • Local Institution
      • Monterrey、Nuevo Leon、墨西哥、64460
        • Local Institution
      • Monterrrey、Nuevo Leon、墨西哥、64700
        • Local Institution
    • Tamaulipas
      • Tampico、Tamaulipas、墨西哥、89109
        • Local Institution
  • 巴西
      • Rio De Janeiro、巴西、20211
        • Local Institution
    • Ceara
      • Fortaleza、Ceara、巴西、60021
        • Local Institution
    • Minas Gerais
      • Itajuba、Minas Gerais、巴西、37502
        • Local Institution
    • Para
      • Belem、Para、巴西、66073
        • Local Institution
    • Rio Grande Do Sul
      • Caxias Do Sul、Rio Grande Do Sul、巴西、95070
        • Local Institution
      • Porto Alegre、Rio Grande Do Sul、巴西、90020090
        • Local Institution
      • Porto Alegre、Rio Grande Do Sul、巴西、90035
        • Local Institution
    • Sao Paulo
      • Marilia、Sao Paulo、巴西、17519
        • Local Institution
  • 美国
    • Arizona
      • Tempe、Arizona、美国、85282
        • Clinical Research Advantage / Desert Clinical Res, Llc
    • California
      • Encino、California、美国、91436
        • Medical Group of Encino
      • Fresno、California、美国、93720
        • Valley Research
      • Los Angeles、California、美国、90023
        • Randall Shue, D.O.
      • Northridge、California、美国、91325
        • Diabetes Medical Center of California
      • San Diego、California、美国、92117
        • Ritchken & First M.D.'S
      • Spring Valley、California、美国、91978
        • Encompass Clinical Research
      • Torrance、California、美国、90505
        • Raikhel, Marina
    • Colorado
      • Colorado Springs、Colorado、美国、80909
        • Express Care Clinical Res
      • Denver、Colorado、美国、80209
        • Denver Internal Medicine
      • Golden、Colorado、美国、80401
        • New West Physicians
    • Florida
      • Altamonte Springs、Florida、美国、32701
        • Central Florida Clinical Trials, Inc.
      • Chipley、Florida、美国、32428
        • Family Care Associates Of Nw Florida
    • Minnesota
      • Minneapolis、Minnesota、美国、56440
        • Health Partners Research Foundation
    • Missouri
      • Chesterfield、Missouri、美国、63017
        • Woodlake Research
    • Nevada
      • Las Vegas、Nevada、美国、89101
        • Nevada Alliance Against Diabetes
    • North Carolina
      • Morehead City、North Carolina、美国、28557
        • Diabetes & Endocrinology Consultants, PC
    • Ohio
      • Newark、Ohio、美国、43055
        • Newark Physician Associates
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73159
        • Integris Family Care S. Penn
    • Pennsylvania
      • Carlisle、Pennsylvania、美国、17013
        • Cumberland Valley Endocrinology Center, Llc
      • Pittsburgh、Pennsylvania、美国、15216
        • Banksville Medical Pc
    • South Carolina
      • Summerville、South Carolina、美国、29485
        • Palmetto Clinical Research
      • Taylors、South Carolina、美国、29687
        • Southeastern Research Assoc
    • Texas
      • Houston、Texas、美国、77081
        • Texas Center For Drug Development, P.A.
      • San Antonio、Texas、美国、78229
        • Diabetes & Glandular Disease Research Associates, Inc.
      • San Antonio、Texas、美国、78229
        • S.A.M. Clinical Research Center
    • Utah
      • Salt Lake City、Utah、美国、84102
        • Optimum Clinical Research
    • Washington
      • Spokane、Washington、美国、99216
        • Office Of Dr. Gray
  • 阿根廷
      • Buenos Aires、阿根廷、1431
        • Local Institution
      • Cordoba、阿根廷、5000
        • Local Institution
    • Buenos Aires
      • Capital Federal、Buenos Aires、阿根廷、1034
        • Local Institution
      • Capital Federal、Buenos Aires、阿根廷、1429
        • Local Institution
      • Capital Federal、Buenos Aires、阿根廷、C1056ABJ
        • Local Institution
      • Capital Federal、Buenos Aires、阿根廷、C1425AGC
        • Local Institution
      • Ciudad Auton、Buenos Aires、阿根廷、C1408INH
        • Local Institution
      • Ciudad Auton.、Buenos Aires、阿根廷、C1505CWB
        • Local Institution
      • Mar Del Plata、Buenos Aires、阿根廷、7600
        • Local Institution
      • Zarate、Buenos Aires、阿根廷、2800
        • Local Institution
    • Cordoba
      • Villa Carlos Paz、Cordoba、阿根廷、5152
        • Local Institution

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 77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

Key Inclusion Criteria

  • Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
  • Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
  • C-peptide ≥1.0 ng/mL
  • Body mass index ≤45.0 kg/m^2
  • Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key Exclusion Criteria

  • Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
  • Serum total bilirubin level >2 mg/dL
  • Creatinine kinase level >3 times upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
  • Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

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
安慰剂比较：Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
药品：Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
药品：Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
实验性的：Dapagliflozin, 2.5 mg + Metformin
Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
药品：Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
药品：Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
其他名称：
  • BMS-512148
实验性的：Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
药品：Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
药品：Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
其他名称：
  • BMS-512148
实验性的：Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
药品：Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
药品：Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
药品：Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
其他名称：
  • BMS-512148

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
第 24 周血红蛋白 A1C (HbA1c) 相对于基线的调整平均变化（上次观察结转 [LOCF]）
大体时间：从基线到第 24 周
HbA1c 由中央实验室测量为血红蛋白的百分比。 抢救药物后的数据被排除在该分析之外。 基线定义为双盲研究药物首次给药开始日期和时间之前的最后一次评估。 在第一次给药时间或评估时间不可用的情况下，基线被定义为双盲研究药物首次给药日期或之前的最后一次评估。 HbA1c 测量值是在双盲期的资格和导入期以及第 1 天和第 4、8、12、16、20 和 24 周获得的。
从基线到第 24 周

次要结果测量

结果测量
措施说明
大体时间
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
大体时间：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
大体时间：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
大体时间：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
大体时间：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
大体时间：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
大体时间：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
大体时间：From Baseline to Week 1
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 1
Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])
大体时间：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24

其他结果措施

结果测量
措施说明
大体时间
Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation
大体时间：From Baseline to end of Long-term Period (Week 102)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.
From Baseline to end of Long-term Period (Week 102)
Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality
大体时间：Day 1 to Week 102
BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.
Day 1 to Week 102
Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])
大体时间：Baseline to Week 102
12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.
Baseline to Week 102
Mean Changes From Baseline in Seated Systolic Blood Pressure
大体时间：From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 102
Mean Changes From Baseline in Seated Diastolic Blood Pressure
大体时间：From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 102
Number of Participants With Orthostatic Hypotension
大体时间：From Baseline to Week 102
Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.
From Baseline to Week 102

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

AstraZeneca

合作者

Bristol-Myers Squibb

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。

一般刊物

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

2007年9月1日

初级完成 (实际的)

2008年11月1日

研究完成 (实际的)

2010年5月1日

研究注册日期

首次提交

2007年9月11日

首先提交符合 QC 标准的

2007年9月11日

首次发布 (估计)

2007年9月12日

研究记录更新

最后更新发布 (估计)

2015年10月20日

上次提交的符合 QC 标准的更新

2015年9月30日

最后验证

2015年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MB102-014 LT
  • MB102-014 (其他标识符：Other Study ID Numbers:)

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.

2型糖尿病的临床试验

Placebo的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Suriname

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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