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

18 de abril de 2017 actualizado 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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

497

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

  • 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
  • Federación Rusa
      • Kursk, Federación Rusa, 305035
        • Local Institution
      • Saint-Petersburg, Federación Rusa, 191015
        • Local Institution
      • Saratov, Federación Rusa, 410012
        • Local Institution
      • Smolensk, Federación Rusa, 214018
        • Local Institution
      • St. Petersburg, Federación Rusa, 195112
        • Local Institution
      • St. Petersburg, Federación Rusa, 195257
        • Local Institution
      • St. Petersburg, Federación Rusa, 197341
        • Local Institution
      • St.Petersburg, Federación Rusa, 197022
        • Local Institution
  • India
      • Ahmedabad, India, 380 015
        • Local Institution
      • Bangalore, India, 560 043
        • Local Institution
      • Bangalore, India, 560 052
        • Local Institution
      • Jaipur, India, 302001
        • Local Institution
      • Jaipur, India, 302016
        • 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
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Local Institution
      • Ponce, Puerto Rico, 00717
        • Local Institution
  • Sudáfrica
    • Gauteng
      • Benoni, Gauteng, Sudáfrica, 1501
        • Local Institution
      • Soweto, Gauteng, Sudáfrica, 1818
        • Local Institution
    • Western Cape
      • Paarl, Western Cape, Sudáfrica, 7646
        • Local Institution
      • Tygerberg, Western Cape, Sudáfrica, 7505
        • 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

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

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
Experimental: Dapagliflozin 1 mg
Dapagliflozin: 1 mg
Droga: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Otros nombres:
  • BMS-512148
  • Farxiga®
Experimental: Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
Droga: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Otros nombres:
  • BMS-512148
  • Farxiga®
Experimental: Dapagliflozin 5 mg
Dapagliflozin: 5 mg
Droga: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Otros nombres:
  • BMS-512148
  • Farxiga®
Comparador de placebos: Placebo
Placebo: 0 mg
Droga: Placebo
Tablets, Oral, Once Daily, Up to 24 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

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 (Actual)

22 de septiembre de 2008

Finalización primaria (Actual)

29 de diciembre de 2009

Finalización del estudio (Actual)

29 de diciembre de 2009

Fechas de registro del estudio

Enviado por primera vez

15 de agosto de 2008

Primero enviado que cumplió con los criterios de control de calidad

15 de agosto de 2008

Publicado por primera vez (Estimar)

18 de agosto de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de abril de 2017

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

18 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MB102-032

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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