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

18 de abril de 2017 atualizado por: 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

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

497

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 77 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dapagliflozin 1 mg
Dapagliflozin: 1 mg
Medicamento: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Outros nomes:
  • BMS-512148
  • Farxiga™
Experimental: Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
Medicamento: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Outros nomes:
  • BMS-512148
  • Farxiga™
Experimental: Dapagliflozin 5 mg
Dapagliflozin: 5 mg
Medicamento: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Outros nomes:
  • BMS-512148
  • Farxiga™
Comparador de Placebo: Placebo
Placebo: 0 mg
Medicamento: Placebo
Tablets, Oral, Once Daily, Up to 24 weeks

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Colaboradores

Bristol-Myers Squibb

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

22 de setembro de 2008

Conclusão Primária (Real)

29 de dezembro de 2009

Conclusão do estudo (Real)

29 de dezembro de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

15 de agosto de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de agosto de 2008

Primeira postagem (Estimativa)

18 de agosto de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de abril de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de abril de 2017

Última verificação

1 de abril de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MB102-032

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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