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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 ottobre 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

936

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Comparatore attivo: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily
Droga: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
Comparatore attivo: 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
Comparatore attivo: 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
Sperimentale: 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
Sperimentale: 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
Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in HbA1c After 30 Weeks of Treatment.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Collaboratori

Eli Lilly and Company

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2010

Completamento primario (Effettivo)

1 febbraio 2013

Completamento dello studio (Effettivo)

1 febbraio 2013

Date di iscrizione allo studio

Primo inviato

16 agosto 2010

Primo inviato che soddisfa i criteri di controllo qualità

16 agosto 2010

Primo Inserito (Stima)

17 agosto 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

20 ottobre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2014

Ultimo verificato

1 ottobre 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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