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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

2015년 9월 30일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

915

단계

  • 3단계

연락처 및 위치

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

연구 장소

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

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

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
위약 비교기: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
의약품: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
의약품: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
실험적: 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
의약품: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
의약품: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
다른 이름들:
  • BMS-512148
실험적: Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
의약품: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
의약품: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
다른 이름들:
  • BMS-512148
실험적: Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
의약품: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
의약품: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
의약품: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
다른 이름들:
  • BMS-512148

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
24주차에 헤모글로빈 A1C(HbA1c)의 기준선에서 조정된 평균 변화(마지막 관찰 이월[LOCF])
기간: 기준선에서 24주차까지
HbA1c는 중앙 실험실에서 헤모글로빈 백분율로 측정되었습니다. 구조 약물 후 데이터는 이 분석에서 제외되었습니다. 기준선은 이중 맹검 연구 약물의 첫 번째 투여 시작 날짜 및 시간 이전의 마지막 평가로 정의되었습니다. 첫 번째 투여 시간 또는 평가 시간을 사용할 수 없는 경우 기준선은 이중 맹검 연구 약물의 첫 번째 투여 날짜 또는 그 이전의 마지막 평가로 정의되었습니다. HbA1c 측정은 검증 및 도입 기간 동안 그리고 이중 맹검 기간의 1일차와 4주, 8주, 12주, 16주, 20주 및 24주차에 이루어졌습니다.
기준선에서 24주차까지

2차 결과 측정

결과 측정
측정값 설명
기간
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
기간: 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])
기간: 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])
기간: 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])
기간: 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])
기간: 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])
기간: 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])
기간: 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])
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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])
기간: 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
기간: 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
기간: 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
기간: 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

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

2007년 9월 1일

기본 완료 (실제)

2008년 11월 1일

연구 완료 (실제)

2010년 5월 1일

연구 등록 날짜

최초 제출

2007년 9월 11일

QC 기준을 충족하는 최초 제출

2007년 9월 11일

처음 게시됨 (추정)

2007년 9월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 10월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 9월 30일

마지막으로 확인됨

2015년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MB102-014 LT
  • MB102-014 (기타 식별자: Other Study ID Numbers:)

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

Placebo에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Cote d'Ivoire

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

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