이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2017년 4월 18일 업데이트: 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

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

497

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dapagliflozin 1 mg
Dapagliflozin: 1 mg
의약품: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
다른 이름들:
  • BMS-512148
  • 포시가™
실험적: Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
의약품: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
다른 이름들:
  • BMS-512148
  • 포시가™
실험적: Dapagliflozin 5 mg
Dapagliflozin: 5 mg
의약품: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
다른 이름들:
  • BMS-512148
  • 포시가™
위약 비교기: Placebo
Placebo: 0 mg
의약품: Placebo
Tablets, Oral, Once Daily, Up to 24 weeks

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

협력자

Bristol-Myers Squibb

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2008년 9월 22일

기본 완료 (실제)

2009년 12월 29일

연구 완료 (실제)

2009년 12월 29일

연구 등록 날짜

최초 제출

2008년 8월 15일

QC 기준을 충족하는 최초 제출

2008년 8월 15일

처음 게시됨 (추정)

2008년 8월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 4월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 4월 18일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MB102-032

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

제2형 당뇨병에 대한 임상 시험

  • Postgraduate Institute of Medical Education and...
    완전한
    2형 간신증후군 (Type2 HRS)
    Type 2 HRS에서 Terlipressin과 Noradrenaline의 안전성과 효능 및 예측반응인자
    인도

Dapagliflozin에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in South Africa

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다