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30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

9 de octubre de 2014 actualizado por: Boehringer Ingelheim

A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

936

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

  • Alemania
      • Bad Lauterberg / Harz, Alemania
        • 1264.3.49001 Boehringer Ingelheim Investigational Site
      • Dietzenbach, Alemania
        • 1264.3.49007 Boehringer Ingelheim Investigational Site
      • Dortmund, Alemania
        • 1264.3.49002 Boehringer Ingelheim Investigational Site
      • Essen, Alemania
        • 1264.3.49009 Boehringer Ingelheim Investigational Site
      • Hamburg, Alemania
        • 1264.3.49003 Boehringer Ingelheim Investigational Site
      • Ingelheim, Alemania
        • 1264.3.49012 Boehringer Ingelheim Investigational Site
      • Leipzig, Alemania
        • 1264.3.49008 Boehringer Ingelheim Investigational Site
      • Mainz, Alemania
        • 1264.3.49005 Boehringer Ingelheim Investigational Site
      • Offenbach, Alemania
        • 1264.3.49010 Boehringer Ingelheim Investigational Site
      • Stuhr, Alemania
        • 1264.3.49004 Boehringer Ingelheim Investigational Site
  • España
      • Badía del Vallès - Barcelona, España
        • 1264.3.34013 Boehringer Ingelheim Investigational Site
      • Barcelona, España
        • 1264.3.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, España
        • 1264.3.34008 Boehringer Ingelheim Investigational Site
      • Borges del Camp- Tarragona, España
        • 1264.3.34005 Boehringer Ingelheim Investigational Site
      • Canet de Mar - Barcelona, España
        • 1264.3.34006 Boehringer Ingelheim Investigational Site
      • Centelles - Barcelona, España
        • 1264.3.34010 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, España
        • 1264.3.34009 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat - Barcelona, España
        • 1264.3.34004 Boehringer Ingelheim Investigational Site
      • Sant Adrià del Besós- Barcelona, España
        • 1264.3.34002 Boehringer Ingelheim Investigational Site
      • Tarrega - Lleida, España
        • 1264.3.34007 Boehringer Ingelheim Investigational Site
      • Valencia, España
        • 1264.3.34012 Boehringer Ingelheim Investigational Site
      • Vic - Barcelona, España
        • 1264.3.34011 Boehringer Ingelheim Investigational Site
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos
        • 1264.3.01026 Boehringer Ingelheim Investigational Site
      • Montgomery, Alabama, Estados Unidos
        • 1264.3.01021 Boehringer Ingelheim Investigational Site
      • Muscle Shoals, Alabama, Estados Unidos
        • 1264.3.01020 Boehringer Ingelheim Investigational Site
    • Arizona
      • Chandler, Arizona, Estados Unidos
        • 1264.3.01062 Boehringer Ingelheim Investigational Site
      • Mesa, Arizona, Estados Unidos
        • 1264.3.01064 Boehringer Ingelheim Investigational Site
    • California
      • Carmichael, California, Estados Unidos
        • 1264.3.01049 Boehringer Ingelheim Investigational Site
      • Chino, California, Estados Unidos
        • 1264.3.01078 Boehringer Ingelheim Investigational Site
      • Concord, California, Estados Unidos
        • 1264.3.01031 Boehringer Ingelheim Investigational Site
      • Lakewood, California, Estados Unidos
        • 1264.3.01037 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, Estados Unidos
        • 1264.3.01065 Boehringer Ingelheim Investigational Site
      • Norwalk, California, Estados Unidos
        • 1264.3.01006 Boehringer Ingelheim Investigational Site
      • Rancho Cucamonga, California, Estados Unidos
        • 1264.3.01001 Boehringer Ingelheim Investigational Site
      • San Diego, California, Estados Unidos
        • 1264.3.01059 Boehringer Ingelheim Investigational Site
      • Tarzana, California, Estados Unidos
        • 1264.3.01023 Boehringer Ingelheim Investigational Site
      • Tustin, California, Estados Unidos
        • 1264.3.01016 Boehringer Ingelheim Investigational Site
      • Valencia, California, Estados Unidos
        • 1264.3.01058 Boehringer Ingelheim Investigational Site
      • Westlake Village, California, Estados Unidos
        • 1264.3.01083 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, Estados Unidos
        • 1264.3.01027 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Norwalk, Connecticut, Estados Unidos
        • 1264.3.01033 Boehringer Ingelheim Investigational Site
    • Florida
      • Boca Raton, Florida, Estados Unidos
        • 1264.3.01035 Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, Estados Unidos
        • 1264.3.01015 Boehringer Ingelheim Investigational Site
      • Hialeah, Florida, Estados Unidos
        • 1264.3.01082 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, Estados Unidos
        • 1264.3.01036 Boehringer Ingelheim Investigational Site
      • Longwood, Florida, Estados Unidos
        • 1264.3.01013 Boehringer Ingelheim Investigational Site
      • Miami, Florida, Estados Unidos
        • 1264.3.01038 Boehringer Ingelheim Investigational Site
      • Miami, Florida, Estados Unidos
        • 1264.3.01042 Boehringer Ingelheim Investigational Site
      • Miami, Florida, Estados Unidos
        • 1264.3.01079 Boehringer Ingelheim Investigational Site
      • Port Orange, Florida, Estados Unidos
        • 1264.3.01019 Boehringer Ingelheim Investigational Site
      • St. Cloud, Florida, Estados Unidos
        • 1264.3.01018 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Estados Unidos
        • 1264.3.01009 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Estados Unidos
        • 1264.3.01012 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos
        • 1264.3.01008 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, Estados Unidos
        • 1264.3.01055 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, Estados Unidos
        • 1264.3.01061 Boehringer Ingelheim Investigational Site
      • Blue Ridge, Georgia, Estados Unidos
        • 1264.3.01074 Boehringer Ingelheim Investigational Site
      • Cartersville, Georgia, Estados Unidos
        • 1264.3.01084 Boehringer Ingelheim Investigational Site
      • Perry, Georgia, Estados Unidos
        • 1264.3.01060 Boehringer Ingelheim Investigational Site
      • Savannah, Georgia, Estados Unidos
        • 1264.3.01050 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, Estados Unidos
        • 1264.3.01077 Boehringer Ingelheim Investigational Site
    • Indiana
      • Brownsburg, Indiana, Estados Unidos
        • 1264.3.01052 Boehringer Ingelheim Investigational Site
      • Evansville, Indiana, Estados Unidos
        • 1264.3.01075 Boehringer Ingelheim Investigational Site
      • Evansville, Indiana, Estados Unidos
        • 1264.3.01076 Boehringer Ingelheim Investigational Site
      • Franklin, Indiana, Estados Unidos
        • 1264.3.01073 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, Estados Unidos
        • 1264.3.01002 Boehringer Ingelheim Investigational Site
      • Wichita, Kansas, Estados Unidos
        • 1264.3.01007 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, Estados Unidos
        • 1264.3.01010 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos
        • 1264.3.01028 Boehringer Ingelheim Investigational Site
      • Sunset, Louisiana, Estados Unidos
        • 1264.3.01029 Boehringer Ingelheim Investigational Site
    • Maryland
      • Hyattsville, Maryland, Estados Unidos
        • 1264.3.01069 Boehringer Ingelheim Investigational Site
    • Michigan
      • Southfield, Michigan, Estados Unidos
        • 1264.3.01066 Boehringer Ingelheim Investigational Site
    • Montana
      • Great Falls, Montana, Estados Unidos
        • 1264.3.01057 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Burlington, North Carolina, Estados Unidos
        • 1264.3.01045 Boehringer Ingelheim Investigational Site
      • Charlotte, North Carolina, Estados Unidos
        • 1264.3.01044 Boehringer Ingelheim Investigational Site
    • Ohio
      • Zanesville, Ohio, Estados Unidos
        • 1264.3.01022 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos
        • 1264.3.01032 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Fleetwood, Pennsylvania, Estados Unidos
        • 1264.3.01051 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, Estados Unidos
        • 1264.3.01025 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Columbia, South Carolina, Estados Unidos
        • 1264.3.01081 Boehringer Ingelheim Investigational Site
      • Greer, South Carolina, Estados Unidos
        • 1264.3.01003 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Kingsport, Tennessee, Estados Unidos
        • 1264.3.01011 Boehringer Ingelheim Investigational Site
    • Texas
      • Corpus Christi, Texas, Estados Unidos
        • 1264.3.01017 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Estados Unidos
        • 1264.3.01067 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Estados Unidos
        • 1264.3.01004 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Estados Unidos
        • 1264.3.01039 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Estados Unidos
        • 1264.3.01041 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Estados Unidos
        • 1264.3.01047 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Estados Unidos
        • 1264.3.01070 Boehringer Ingelheim Investigational Site
      • Killeen, Texas, Estados Unidos
        • 1264.3.01040 Boehringer Ingelheim Investigational Site
      • Midland, Texas, Estados Unidos
        • 1264.3.01048 Boehringer Ingelheim Investigational Site
      • New Braunfels, Texas, Estados Unidos
        • 1264.3.01030 Boehringer Ingelheim Investigational Site
      • North Richland Hills, Texas, Estados Unidos
        • 1264.3.01071 Boehringer Ingelheim Investigational Site
      • Plano, Texas, Estados Unidos
        • 1264.3.01085 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, Estados Unidos
        • 1264.3.01046 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, Estados Unidos
        • 1264.3.01056 Boehringer Ingelheim Investigational Site
  • Estonia
      • Harju, Estonia
        • 1264.3.37207 Boehringer Ingelheim Investigational Site
      • Pärnu, Estonia
        • 1264.3.37209 Boehringer Ingelheim Investigational Site
      • Tallin, Estonia
        • 1264.3.37203 Boehringer Ingelheim Investigational Site
      • Tallin, Estonia
        • 1264.3.37204 Boehringer Ingelheim Investigational Site
      • Tallin, Estonia
        • 1264.3.37205 Boehringer Ingelheim Investigational Site
      • Tallinn, Estonia
        • 1264.3.37201 Boehringer Ingelheim Investigational Site
      • Tallinn, Estonia
        • 1264.3.37202 Boehringer Ingelheim Investigational Site
      • Tallinn, Estonia
        • 1264.3.37208 Boehringer Ingelheim Investigational Site
      • Tartu, Estonia
        • 1264.3.37206 Boehringer Ingelheim Investigational Site
      • Viljandi County, Estonia
        • 1264.3.37210 Boehringer Ingelheim Investigational Site
  • Letonia
      • Daugavpils, Letonia
        • 1264.3.37105 Boehringer Ingelheim Investigational Site
      • Daugavpils, Letonia
        • 1264.3.37112 Boehringer Ingelheim Investigational Site
      • Daugavpils, Letonia
        • 1264.3.37113 Boehringer Ingelheim Investigational Site
      • Jelgava, Letonia
        • 1264.3.37110 Boehringer Ingelheim Investigational Site
      • Liepaja, Letonia
        • 1264.3.37101 Boehringer Ingelheim Investigational Site
      • Ogre, Letonia
        • 1264.3.37106 Boehringer Ingelheim Investigational Site
      • Riga, Letonia
        • 1264.3.37104 Boehringer Ingelheim Investigational Site
      • Riga, Letonia
        • 1264.3.37108 Boehringer Ingelheim Investigational Site
      • Riga, Letonia
        • 1264.3.37109 Boehringer Ingelheim Investigational Site
      • Riga, Letonia
        • 1264.3.37111 Boehringer Ingelheim Investigational Site
      • Talsi, Letonia
        • 1264.3.37107 Boehringer Ingelheim Investigational Site
      • Tukums, Letonia
        • 1264.3.37102 Boehringer Ingelheim Investigational Site
      • Valmiera, Letonia
        • 1264.3.37103 Boehringer Ingelheim Investigational Site
  • Reino Unido
      • Annan, Reino Unido
        • 1264.3.44032 Boehringer Ingelheim Investigational Site
      • Ash Vale, Aldershot, Reino Unido
        • 1264.3.44028 Boehringer Ingelheim Investigational Site
      • Baillieston, Glasgow, Reino Unido
        • 1264.3.44029 Boehringer Ingelheim Investigational Site
      • Balham, Reino Unido
        • 1264.3.44008 Boehringer Ingelheim Investigational Site
      • Bradford on Avon, Reino Unido
        • 1264.3.44021 Boehringer Ingelheim Investigational Site
      • Burbage, Reino Unido
        • 1264.3.44019 Boehringer Ingelheim Investigational Site
      • Chesterfield, Reino Unido
        • 1264.3.44012 Boehringer Ingelheim Investigational Site
      • Chestfield, Whitstable, Reino Unido
        • 1264.3.44027 Boehringer Ingelheim Investigational Site
      • Chippenham, Reino Unido
        • 1264.3.44011 Boehringer Ingelheim Investigational Site
      • Johnstone, Reino Unido
        • 1264.3.44033 Boehringer Ingelheim Investigational Site
      • Midsomer Norton, Reino Unido
        • 1264.3.44007 Boehringer Ingelheim Investigational Site
      • Paisley, Reino Unido
        • 1264.3.44034 Boehringer Ingelheim Investigational Site
      • Warminster, Reino Unido
        • 1264.3.44031 Boehringer Ingelheim Investigational Site

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 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
  3. Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
  4. BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
  5. Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
  2. Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
  3. Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
  4. Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
  5. Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
  6. Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)

  7. Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :

    • Diagnose of heart failure or history of heart failure
    • Haemodialysis patients, due to limited experience with pioglitazone
  8. Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
  9. Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
  10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
  11. Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
  12. Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  13. Participation in another trial with an investigational drug within 30 days prior to informed consent
  14. Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures

  15. Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.

    A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner

  16. Symptomatic gallbladder disease in the last six months
  17. Medical history of pancreatitis.
  18. Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
  19. Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.

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 activo: Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily
Droga: Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
Comparador activo: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily
Droga: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
Comparador activo: Pioglitazone 45 mg
Pioglitazone Capsules 45 mg once daily
Droga: Pioglitazone 45 mg
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
Comparador activo: Linagliptin 5mg
Linagliptin 5mg Tablets once daily
Droga: Linagliptin 5mg
Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Experimental: Linagliptin 5mg / Pioglitazone 15 mg
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
Droga: Linagliptin 5mg / Pioglitazone 15 mg FDC
Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Experimental: Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
Droga: Linagliptin 5mg / Pioglitazone 30 mg FDC
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
Experimental: Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
Droga: Linagliptin 5mg / Pioglitazone 45 mg FDC
Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in HbA1c After 30 Weeks of Treatment.
Periodo de tiempo: Baseline and 30 weeks
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
Baseline and 30 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Periodo de tiempo: Baseline and 30 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
Periodo de tiempo: Baseline and 30 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
Periodo de tiempo: Baseline and 30 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
HbA1c Change From Baseline by Visit Over Time
Periodo de tiempo: Baseline, week 6, week 12, week 18, week 24, week 30

HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.

by visit interaction.
Baseline, week 6, week 12, week 18, week 24, week 30
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
Periodo de tiempo: Baseline and 30 weeks
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
Baseline and 30 weeks
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Periodo de tiempo: Baseline, week 6, week 12, week 18, week 24, week 30
The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction
Baseline, week 6, week 12, week 18, week 24, week 30
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
Periodo de tiempo: Baseline and 30 weeks
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
Baseline and 30 weeks
Time to First Use of Rescue Therapy
Periodo de tiempo: 30 weeks
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
30 weeks
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
Periodo de tiempo: 30 weeks
Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.
30 weeks

Colaboradores e Investigadores

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

Patrocinador

Boehringer Ingelheim

Colaboradores

Eli Lilly and Company

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.

Enlaces Útiles

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 agosto de 2010

Finalización primaria (Actual)

1 de febrero de 2013

Finalización del estudio (Actual)

1 de febrero de 2013

Fechas de registro del estudio

Enviado por primera vez

16 de agosto de 2010

Primero enviado que cumplió con los criterios de control de calidad

16 de agosto de 2010

Publicado por primera vez (Estimar)

17 de agosto de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

20 de octubre de 2014

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

9 de octubre de 2014

Última verificación

1 de octubre de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1264.3
  • 2008-008127-15 (Número EudraCT: EudraCT)

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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