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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

30 de setembro de 2015 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

915

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

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

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

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
Comparador de Placebo: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Medicamento: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Medicamento: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Experimental: 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
Medicamento: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Medicamento: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Outros nomes:
  • BMS-512148
Experimental: Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Medicamento: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Medicamento: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Outros nomes:
  • BMS-512148
Experimental: Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Medicamento: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Medicamento: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Medicamento: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Outros nomes:
  • BMS-512148

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Alteração média ajustada da linha de base na hemoglobina A1C (HbA1c) na semana 24 (última observação realizada [LOCF])
Prazo: Da linha de base até a semana 24
HbA1c foi medida como porcentagem de hemoglobina por um laboratório central. Os dados após a medicação de resgate foram excluídos desta análise. A linha de base foi definida como a última avaliação antes da data e hora de início da primeira dose da medicação do estudo duplo-cego. Nos casos em que o horário da primeira dose ou da avaliação não estava disponível, a linha de base foi definida como a última avaliação na data ou antes da data da primeira dose da medicação em estudo duplo-cego. As medições de HbA1c foram obtidas durante os períodos de qualificação e introdução e no Dia 1 e nas Semanas 4, 8, 12, 16, 20 e 24 no período duplo-cego.
Da linha de base até a semana 24

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Prazo: 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])
Prazo: 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])
Prazo: 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])
Prazo: 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])
Prazo: 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])
Prazo: 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])
Prazo: 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])
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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])
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

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

1 de setembro de 2007

Conclusão Primária (Real)

1 de novembro de 2008

Conclusão do estudo (Real)

1 de maio de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

11 de setembro de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de setembro de 2007

Primeira postagem (Estimativa)

12 de setembro de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

20 de outubro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de setembro de 2015

Última verificação

1 de setembro de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MB102-014 LT
  • MB102-014 (Outro identificador: Other Study ID Numbers:)

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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