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Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes

4 de marzo de 2016 actualizado por: Takeda

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared With Placebo in Subjects With Type 2 Diabetes

The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

TAK-875 is being developed at Takeda Development Center, Inc. as an adjunct to diet and exercise to improve glycemic control in patients with T2DM.

This study will investigate TAK-875 in participants with type 2 diabetes mellitus who have been treated with only diet and exercise for at least 12 weeks prior to Screening, who have taken ≤7 days of any antidiabetic agent within the 12 weeks prior to Screening, and whose glycemic control is inadequate.

Tipo de estudio

Intervencionista

Inscripción (Actual)

421

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
      • Ciudad Autonoma Buenos Aires, Argentina
      • Cordoba, Argentina
      • Corrientes, Argentina
      • Mendoza, Argentina
    • Ciudad Autonoma Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
    • Cordoba
      • Villa Cabrera, Cordoba, Argentina
  • Bulgaria
      • Byala, Bulgaria
      • Plovdiv, Bulgaria
      • Ruse, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Eslovaquia
      • Banska Bystrica, Eslovaquia
      • Bratislava, Eslovaquia
      • Dolny Kubin, Eslovaquia
      • Komarno, Eslovaquia
      • Levice, Eslovaquia
      • Pezinok, Eslovaquia
      • Prievidza, Eslovaquia
      • Trebisov, Eslovaquia
      • Trencin, Eslovaquia
      • Zilina, Eslovaquia
  • Estados Unidos
    • Alabama
      • Dothan, Alabama, Estados Unidos
      • Muscle Shoals, Alabama, Estados Unidos
    • Arizona
      • Goodyear, Arizona, Estados Unidos
      • Phoenix, Arizona, Estados Unidos
    • California
      • Long Beach, California, Estados Unidos
      • North Hollywood, California, Estados Unidos
      • Norwalk, California, Estados Unidos
      • Palm Springs, California, Estados Unidos
      • Pismo Beach, California, Estados Unidos
    • Florida
      • Boynton Beach, Florida, Estados Unidos
      • Bradenton, Florida, Estados Unidos
      • Coral Gables, Florida, Estados Unidos
      • Hialeah, Florida, Estados Unidos
      • Largo, Florida, Estados Unidos
      • New Port Richey, Florida, Estados Unidos
      • Orlando, Florida, Estados Unidos
      • Pembroke Pines, Florida, Estados Unidos
    • Georgia
      • Decatur, Georgia, Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos
    • Indiana
      • Avon, Indiana, Estados Unidos
      • Greenfield, Indiana, Estados Unidos
      • Muncie, Indiana, Estados Unidos
    • Iowa
      • Council Bluffs, Iowa, Estados Unidos
    • Kansas
      • Topeka, Kansas, Estados Unidos
    • Kentucky
      • Lexington, Kentucky, Estados Unidos
    • Maryland
      • Oxon Hill, Maryland, Estados Unidos
    • Michigan
      • Flint, Michigan, Estados Unidos
    • Mississippi
      • Picayune, Mississippi, Estados Unidos
    • Nebraska
      • Omaha, Nebraska, Estados Unidos
    • New Jersey
      • Elizabeth, New Jersey, Estados Unidos
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos
      • Greensboro, North Carolina, Estados Unidos
      • Mooresville, North Carolina, Estados Unidos
      • Morganton, North Carolina, Estados Unidos
      • Raleigh, North Carolina, Estados Unidos
    • Ohio
      • Maumee, Ohio, Estados Unidos
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos
    • Pennsylvania
      • Harleysville, Pennsylvania, Estados Unidos
      • Levittown, Pennsylvania, Estados Unidos
      • Uniontown, Pennsylvania, Estados Unidos
    • South Carolina
      • Greer, South Carolina, Estados Unidos
    • Tennessee
      • Crossville, Tennessee, Estados Unidos
    • Texas
      • Carrollton, Texas, Estados Unidos
      • Dallas, Texas, Estados Unidos
      • El Pasco, Texas, Estados Unidos
      • Fort Worth, Texas, Estados Unidos
      • Ft. Worth, Texas, Estados Unidos
      • Houston, Texas, Estados Unidos
      • Irving, Texas, Estados Unidos
      • New Braunfels, Texas, Estados Unidos
      • San Antonio, Texas, Estados Unidos
      • Spring, Texas, Estados Unidos
      • Tomball, Texas, Estados Unidos
    • Utah
      • Salt Lake City, Utah, Estados Unidos
    • Virginia
      • Burke, Virginia, Estados Unidos
      • Manassas, Virginia, Estados Unidos
  • Guatemala
      • Guatemala, Guatemala
      • Guatemala City, Guatemala
      • Quetzaltenango, Guatemala
      • Zacapa, Guatemala
  • Hungría
      • Budapest, Hungría
      • Debrecen, Hungría
      • Kecskemet, Hungría
      • Komarom, Hungría
      • Szikszo, Hungría
      • Zalaegerszeg, Hungría
  • México
    • Distrito Federal
      • Mexico, Distrito Federal, México
    • Nuevo León
      • Monterrey, Nuevo León, México
  • Ucrania
      • Dnipropetrovsk, Ucrania
      • Kharkiv, Ucrania
      • Kyiv, Ucrania
      • Odesa, Ucrania
      • Simferopol, Ucrania
      • Ternopil, Ucrania
      • Vinnytsia, Ucrania
      • Zaporizhzhia, Ucrania

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  3. The participant is male or female and 18 years of age or older with a historical diagnosis of T2DM.
  4. The participant has been treated with only diet and exercise for at least 12 weeks prior to Screening and has an HbA1c concentration between 7.0 % and 10.5%, inclusive, at Screening.
  5. The participant has received ≤7 days of any antidiabetic agent within 12 weeks prior to Screening.
  6. The participant has a body mass index (BMI) ≤45 kg/m^2 at Screening.
  7. Participants regularly using other, non-excluded medications must be on a stable dose for at least 4 weeks prior to Screening. However, as needed (PRN) use of prescription or over-the-counter medication is allowed at the discretion of the investigator.
  8. The participant is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete participant diaries.
  9. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose of study drug.

Additional Inclusion Criteria prior to Randomization

  1. The participant has an HbA1c concentration between 7.0 and 10.5%, inclusive, and a fasting plasma glucose (FPG) ≤270 mg/dL (≤15.0 mmol/L) at Week -1 Visit. (If the participant does not qualify for randomization based on these criteria, the assessments may be repeated weekly, for a maximum of 2 additional weeks).
  2. The participant's overall compliance with single-blind study medication during the Placebo Run-in Period is at least 75% and does not exceed 125% based on tablet counts performed by the study staff.
  3. A female participant of childbearing potential must have a negative urine hCG pregnancy test at Baseline (Visit 4) prior to Randomization and prior to administration of the first dose of double-blind study medication

Exclusion Criteria:

  1. The participant has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within 3 months prior to Screening.
  2. The participant has been randomized in a previous TAK-875 study.
  3. The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, or sibling; biological or legally adopted) or may consent under duress.
  4. The participant donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
  5. The participant has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening.
  6. The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Screening (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).
  7. The participant has a history of cancer that has been in remission for <5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
  8. The participant has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x the upper limit of normal (ULN) at Screening.
  9. The participant has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome, the participant will be allowed with an elevated bilirubin level per the investigator's discretion.
  10. The participant has a serum creatinine ≥1.5 mg/dL(≥133 µmol/L) [males] and ≥1.4 mg/dL (≥124 µmol/L) [females] and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m^2 at Screening.
  11. The participant has uncontrolled thyroid disease.
  12. The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
  13. The participant has had gastric banding or gastric bypass surgery within one year prior to Screening.
  14. The participant has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
  15. The participant had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram (ECG), cerebrovascular accident or transient ischemic attack within 3 months prior or at Screening.
  16. The participant has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875.
  17. The participant has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
  18. The participant received excluded medications prior to Screening or is expected to receive excluded medication.
  19. If female, the participant is pregnant (confirmed by laboratory testing, i.e., serum human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
  20. The participant is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
  21. The participant has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the participant according to the protocol.

Additional Exclusion Criteria prior to Randomization

  1. The participant received excluded medications during the Placebo Run-in Period. (Topical and inhaled corticosteroids are allowed).
  2. The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Baseline (Visit 4) (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).

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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
Droga: Placebo
Comprimidos equivalentes a placebo de fasiglifam
Experimental: Fasiglifam 25 mg
Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
Droga: Fasiglifam
Tabletas de fasiglifam
Experimental: Fasiglifam 50 mg
Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
Droga: Fasiglifam
Tabletas de fasiglifam

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Periodo de tiempo: Baseline and Week 24
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.
Baseline and Week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of HbA1c <7%
Periodo de tiempo: Week 24
The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24.
Week 24
Change From Baseline in Fasting Plasma Glucose
Periodo de tiempo: Baseline and Week 24
The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL). A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.
Baseline and Week 24
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)
Periodo de tiempo: Baseline and Week 24
The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L). An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis.
Baseline and Week 24

Colaboradores e Investigadores

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

Patrocinador

Takeda

Investigadores

  • Director de estudio: Senior Medical Director, Takeda

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 noviembre de 2011

Finalización primaria (Actual)

1 de julio de 2013

Finalización del estudio (Actual)

1 de julio de 2013

Fechas de registro del estudio

Enviado por primera vez

18 de octubre de 2011

Primero enviado que cumplió con los criterios de control de calidad

18 de octubre de 2011

Publicado por primera vez (Estimar)

20 de octubre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de abril de 2016

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

4 de marzo de 2016

Última verificación

1 de marzo de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TAK-875_301
  • 2011-002741-35 (Número EudraCT)
  • U1111-1124-2154 (Identificador de registro: WHO)

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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