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Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

2017年4月18日 更新者：AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise 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)

497

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

  • 俄罗斯联邦
      • Kursk、俄罗斯联邦、305035
        • Local Institution
      • Saint-Petersburg、俄罗斯联邦、191015
        • Local Institution
      • Saratov、俄罗斯联邦、410012
        • Local Institution
      • Smolensk、俄罗斯联邦、214018
        • Local Institution
      • St. Petersburg、俄罗斯联邦、195112
        • Local Institution
      • St. Petersburg、俄罗斯联邦、195257
        • Local Institution
      • St. Petersburg、俄罗斯联邦、197341
        • Local Institution
      • St.Petersburg、俄罗斯联邦、197022
        • Local Institution
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T3C 3P1
        • Local Institution
    • British Columbia
      • Coquitlam、British Columbia、加拿大、V3K 3V9
        • Local Institution
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3E 3P4
        • Local Institution
    • New Brunswick
      • Bathurst、New Brunswick、加拿大、E2A 4X7
        • Local Institution
    • Ontario
      • Ajax、Ontario、加拿大、L1S 7J5
        • Local Institution
      • Toronto、Ontario、加拿大、M9W 4L6
        • Local Institution
      • Waterloo、Ontario、加拿大、N2T 2Z6
        • Local Institution
    • Quebec
      • Drummondville、Quebec、加拿大、J2B 7T1
        • Local Institution
      • L'Ancienne Lorette、Quebec、加拿大、G2E 2X1
        • Local Institution
      • St-Leonard、Quebec、加拿大、H1S 3A9
        • Local Institution
  • 南非
    • Gauteng
      • Benoni、Gauteng、南非、1501
        • Local Institution
      • Soweto、Gauteng、南非、1818
        • Local Institution
    • Western Cape
      • Paarl、Western Cape、南非、7646
        • Local Institution
      • Tygerberg、Western Cape、南非、7505
        • Local Institution
  • 印度
      • Ahmedabad、印度、380 015
        • Local Institution
      • Bangalore、印度、560 043
        • Local Institution
      • Bangalore、印度、560 052
        • Local Institution
      • Jaipur、印度、302001
        • Local Institution
      • Jaipur、印度、302016
        • Local Institution
  • 墨西哥
      • Durango、墨西哥、34000
        • Local Institution
      • Mexico City、墨西哥、06700
        • Local Institution
      • Veracruz、墨西哥、91910
        • Local Institution
    • Distrito Federal
      • Df、Distrito Federal、墨西哥、11800
        • Local Institution
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44670
        • Local Institution
    • Nuevo Leon
      • Monterrey、Nuevo Leon、墨西哥、64060
        • Local Institution
    • Yucatan
      • Merida、Yucatan、墨西哥、97070
        • Local Institution
  • 波多黎各
      • Ponce、波多黎各、00716
        • Local Institution
      • Ponce、波多黎各、00717
        • Local Institution
  • 美国
    • Arizona
      • Litchfield Park、Arizona、美国、85340
        • Dedicated Clinical Research
      • Phoenix、Arizona、美国、85051
        • 43rd Medical Associates, P.C.
      • Tempe、Arizona、美国、85282
        • Clinical Research Advantage, Inc.
    • California
      • Fresno、California、美国、93720
        • Valley Research
      • Lomita、California、美国、90717
        • Marina Raikhel, Md, Faafp
      • Los Gatos、California、美国、95032
        • Richard S. Cherlin, MD
      • Tustin、California、美国、92780
        • Orange County Research Center
    • Colorado
      • Greeley、Colorado、美国、80634
        • Family Physicians Of Greeley
    • Connecticut
      • New London、Connecticut、美国、06320
        • Coastal Connecticut Research, LLC
    • Florida
      • Altamonte Springs、Florida、美国、32701
        • Central Florida Clinical Trials, Inc.
      • Jacksonville、Florida、美国、32205
        • Westside Center for Clinical Research
      • Marianna、Florida、美国、32446
        • Panhandle Family Care Associates
    • Georgia
      • Roswell、Georgia、美国、30076
        • Endocrine Research Solutions, Inc.
    • Mississippi
      • Belzoni、Mississippi、美国、39038
        • Belzoni Clinical Research
    • New Jersey
      • Hamilton、New Jersey、美国、08690
        • R-Research
    • New York
      • Syracuse、New York、美国、13210
        • Internist Associates Of Central New York
      • West Seneca、New York、美国、14224
        • Southgate Medical Group
    • North Carolina
      • Morehead City、North Carolina、美国、28557
        • Down East Medical Associates, PA
    • Ohio
      • Akron、Ohio、美国、44319
        • James J. Brown, Md
    • Oklahoma
      • Oklahoma、Oklahoma、美国、73170
        • Integris Family Care South
    • South Carolina
      • Taylors、South Carolina、美国、29687
        • Southeastern Research Associates, Inc.
    • Texas
      • San Antonio、Texas、美国、78224
        • Abbott Clinical Research Group, Inc
    • Utah
      • Midvale、Utah、美国、84047
        • Avastra Clinical Trials
      • Salt Lake City、Utah、美国、84102
        • Optimum Clinical Research, Inc.
    • Washington
      • Olympia、Washington、美国、98502
        • Capital Clinical Research Center
      • Spokane、Washington、美国、99216
        • Stephen G. Danley, Do

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

Inclusion Criteria:

  • Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
  • Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
  • C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
  • Body Mass Index ≤ 45 kg/m²
  • Must be able to perform self monitoring of blood glucose

Exclusion Criteria:

  • aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)
  • Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
  • Creatinine kinase >3* ULN
  • Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, 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
实验性的：Dapagliflozin 1 mg
Dapagliflozin: 1 mg
药品：Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
其他名称：
  • BMS-512148
  • 法西加™
实验性的：Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
药品：Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
其他名称：
  • BMS-512148
  • 法西加™
实验性的：Dapagliflozin 5 mg
Dapagliflozin: 5 mg
药品：Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
其他名称：
  • BMS-512148
  • 法西加™
安慰剂比较：Placebo
Placebo: 0 mg
药品：Placebo
Tablets, Oral, Once Daily, Up to 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
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
大体时间：Baseline (Day 1), Week 24
Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) 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. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
Baseline (Day 1), Week 24

次要结果测量

结果测量
措施说明
大体时间
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
大体时间：Baseline (Day 1), Week 24
Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined. Data after rescue medication (metformin) 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 was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.
Baseline (Day 1), Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants
大体时间：Baseline (Day 1), Week 24
Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. 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.
Baseline (Day 1), Week 24
Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants
大体时间：Baseline (Day 1), Week 24
Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control. At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in 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 double-blind study medication.
Baseline (Day 1), Week 24
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants
大体时间：Baseline (Day 1), Week 24
Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Baseline (Day 1), Week 24
Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants
大体时间：Baseline (Day 1), Week 24
Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. 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.
Baseline (Day 1), Week 24
Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
大体时间：Day 1 of Double Blind Period to end of Week 24 Plus 30 days
Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 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. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included.
Day 1 of Double Blind Period to end of Week 24 Plus 30 days
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
大体时间：Baseline to last dose plus 4 days in 12 Week Double Blind Period
Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.
Baseline to last dose plus 4 days in 12 Week Double Blind Period
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants
大体时间：Baseline (Day 1), Week 24
Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg). 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.
Baseline (Day 1), Week 24
Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants
大体时间：Baseline (Day 1), Week 24
Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). 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.
Baseline (Day 1), Week 24
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
大体时间：Week 24
12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter.
Week 24
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
大体时间：Baseline to Week 24/end of treatment plus 4 days
Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX, >=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN.
Baseline to Week 24/end of treatment plus 4 days

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 (实际的)

2008年9月22日

初级完成 (实际的)

2009年12月29日

研究完成 (实际的)

2009年12月29日

研究注册日期

首次提交

2008年8月15日

首先提交符合 QC 标准的

2008年8月15日

首次发布 (估计)

2008年8月18日

研究记录更新

最后更新发布 (实际的)

2017年4月20日

上次提交的符合 QC 标准的更新

2017年4月18日

最后验证

2017年4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

  • MB102-032

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.

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