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The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

15. februar 2017 opdateret af: Janssen Research & Development, LLC

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group, 3 arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 450 patients with inadequate glycemic control with diet and exercise will receive once-daily treatment with canagliflozin 100 mg or 300 mg once daily for 52 weeks or 26 weeks of double-blind treatment with placebo followed by 26 weeks of sitagliptin 100 mg (sitagliptin is an antihyperglycemic agent that will allow patients randomized to the placebo group to improve glycemic control and remain in the study). Patients will participate in the study for approximately 60 to 68 weeks (referred to as the Main Study). The study will also include a High Glycemic Substudy in 50 to 100 patients with T2DM who have poorer glycemic control with diet and exercise. Patients in the substudy will be assigned to receive double-blind canagliflozin 100 mg or 300 mg for 26 weeks and the total duration of patient participatation in the substudy will be approximately 34 to 42 weeks. During treatment, if a patient's fasting blood sugar remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single blind placebo for 1 or 2 weeks (wks) before randomization to the Main Study or the High Glycemic Substudy.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

678

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
  • Estland
      • Pärnu, Estland
      • Tartu, Estland
      • Viljandi, Estland
  • Filippinerne
      • Makati, Filippinerne
      • Manila, Filippinerne
      • Marikina City, Filippinerne
      • Pasay, Filippinerne
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater
    • California
      • Concord, California, Forenede Stater
      • Greenbrae, California, Forenede Stater
      • Los Angeles, California, Forenede Stater
      • Spring Valley, California, Forenede Stater
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater
      • Denver, Colorado, Forenede Stater
      • Northglenn, Colorado, Forenede Stater
    • Illinois
      • Springfield, Illinois, Forenede Stater
    • Indiana
      • Evansville, Indiana, Forenede Stater
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater
      • Metairie, Louisiana, Forenede Stater
    • New Jersey
      • Meridian, New Jersey, Forenede Stater
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
    • New York
      • New York, New York, Forenede Stater
      • West Seneca, New York, Forenede Stater
    • North Carolina
      • Mooresville, North Carolina, Forenede Stater
    • Pennsylvania
      • Perryopolis, Pennsylvania, Forenede Stater
      • Pittsburgh, Pennsylvania, Forenede Stater
    • South Carolina
      • Taylors, South Carolina, Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater
      • Houston, Texas, Forenede Stater
      • San Antonio, Texas, Forenede Stater
    • Virginia
      • Norfolk, Virginia, Forenede Stater
  • Guatemala
      • Guatemala, Guatemala
  • Indien
      • Bangalore, Indien
      • Hyderabad, Indien
      • Nagpur, Indien
  • Island
      • Reykjavik, Island
  • Korea, Republikken
      • Busan, Korea, Republikken
      • Goyang-Si, Korea, Republikken
      • Jeonju-Si, Korea, Republikken
      • Seoul, Korea, Republikken
      • Wonju-Si, Korea, Republikken
  • Litauen
      • Kaunas, Litauen
      • Klaipeda, Litauen
      • Siauliai, Litauen
      • Vilnius, Litauen
      • Vilnius Lt, Litauen
  • Malaysia
      • Kelantan, Malaysia
      • Kuala Lumpur, Malaysia
      • Kuala Lumpur N/A, Malaysia
  • Mexico
      • Aguascalientes, Mexico
      • Guadalajara, Mexico
      • Mex, Mexico
      • Monterrey, Mexico
      • Zapopan, Mexico
  • Polen
      • Katowice, Polen
      • Torun, Polen
      • Warszawa, Polen
  • Puerto Rico
      • Fajardo, Puerto Rico
      • Ponce, Puerto Rico
      • San Juan, Puerto Rico
  • Rumænien
      • Baia Mare, Rumænien
      • Brasov, Rumænien
      • Bucharest, Rumænien
      • Targu Mures, Rumænien
  • Spanien
      • Alcala De Henares, Spanien
      • Elche, Spanien
      • Girona, Spanien
      • Pozuelo De Alarcon, Spanien
  • Sverige
      • Göteborg, Sverige
      • Lund, Sverige
      • Malmö, Sverige
      • Skene, Sverige
  • Sydafrika
      • Halfway, Sydafrika
      • Pretoria, Sydafrika
  • Østrig
      • Horn, Østrig
      • Salzburg, Østrig
      • Wien, Østrig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • All patients must have a diagnosis of T2DM
  • Patients in the main study must have a Hemoglobin A1c (HbA1c) between >=7% and <=10% and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
  • Patients in the High Glycemic Cohort Substudy must have an HbA1c between >10% and <=12% and a FPG <=350 mg/dL (19.44 mmol/L)

Exclusion Criteria:

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
Medicin: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy)
Eksperimentel: Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
Medicin: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy)
Eksperimentel: Placebo/Sitagliptin
In the Main Study, each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52.
Medicin: Placebo
One matching placebo capsule orally once daily for 26 weeks (Main Study)
Medicin: Sitagliptin
One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HbA1c From Baseline to Week 26 (Main Study)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Day 1 (Baseline) and Week 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Patients With HbA1c <7% at Week 26 (Main Study)
Tidsramme: Week 26
The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Percent Change in Body Weight From Baseline to Week 26 (Main Study)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Day 1 (Baseline) and Week 26
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Percent Change in Triglycerides From Baseline to Week 26 (Main Study)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Day 1 (Baseline) and Week 26
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Day 1 (Baseline) and Week 26
Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)
Tidsramme: Week 26
The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Day 1 (Baseline) and Week 26
Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Day 1 (Baseline) and Week 26
Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Day 1 (Baseline) and Week 26
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Day 1 (Baseline) and Week 26
Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Day 1 (Baseline) and Week 26
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Day 1 (Baseline) and Week 26

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2010

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. marts 2012

Datoer for studieregistrering

Først indsendt

4. marts 2010

Først indsendt, der opfyldte QC-kriterier

4. marts 2010

Først opslået (Skøn)

5. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2017

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR017011
  • 28431754DIA3005 (Anden identifikator: Janssen Research & Development, LLC)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med Canagliflozin

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