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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 septiembre de 2015 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

915

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 77 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Droga: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Droga: 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
Droga: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Droga: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Otros nombres:
  • 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
Droga: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Droga: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Otros nombres:
  • 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
Droga: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Droga: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Droga: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Otros nombres:
  • BMS-512148

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio medio ajustado desde el inicio en la hemoglobina A1C (HbA1c) en la semana 24 (última observación realizada [LOCF])
Periodo de tiempo: Desde el inicio hasta la semana 24
La HbA1c se midió como porcentaje de hemoglobina en un laboratorio central. Los datos posteriores a la medicación de rescate se excluyeron de este análisis. El valor inicial se definió como la última evaluación antes de la fecha y hora de inicio de la primera dosis del medicamento del estudio doble ciego. En los casos en los que la hora de la primera dosis o la hora de la evaluación no estuviera disponible, el valor inicial se definió como la última evaluación en la fecha de la primera dosis del medicamento del estudio doble ciego o antes de esta. Las mediciones de HbA1c se obtuvieron durante los períodos de calificación y de introducción y el día 1 y las semanas 4, 8, 12, 16, 20 y 24 en el período doble ciego.
Desde el inicio hasta la semana 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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
Periodo de tiempo: 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])
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Colaboradores

Bristol-Myers Squibb

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2007

Finalización primaria (Actual)

1 de noviembre de 2008

Finalización del estudio (Actual)

1 de mayo de 2010

Fechas de registro del estudio

Enviado por primera vez

11 de septiembre de 2007

Primero enviado que cumplió con los criterios de control de calidad

11 de septiembre de 2007

Publicado por primera vez (Estimar)

12 de septiembre de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

20 de octubre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

30 de septiembre de 2015

Última verificación

1 de septiembre de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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