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A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus

27. oktober 2014 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 Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

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), placebo-controlled, parallel-group, 3-arm (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 with T2DM who are not achieving an adequate response from current antihyperglycemic therapy to control their diabetes. Approximately 720 older (55 to 80 years of age) patients with T2DM who are either not on an antihyperglycemic agent or who are receiving treatment with a stable regimen of antihyperglycemic agent(s) and have inadequate glycemic (blood sugar) control will receive once daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 104 weeks (includes 26 weeks of double-blind treatment followed by a 78-week extension period). In addition, all patients will take stable doses of the antihyperglycemic agent(s) that they were taking before entry in the study for the duration of the study. Patients will participate in the study for approximately 108 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with an antihyperglycemic agent (rescue therapy) that is considered clinically appropriate and consistent with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, measures of bone health, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome measure in the study is the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. All patients will take single-blind placebo capsules for 2 weeks before randomization. After randomization, patients will take double blind canagliflozin (100 mg or 300 mg) or matching placebo for 104 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

716

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Fremantle, Australien
      • Heidelberg Heights, Australien
      • Meadowbrook, Australien
      • Richmond, Australien
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canada
    • Ontario
      • Barrie, Ontario, Canada
      • London, Ontario, Canada
      • Markham, Ontario, Canada
      • Oakville, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige
      • Cardiff, Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige
      • Liverpool, Det Forenede Kongerige
      • Manchester, Det Forenede Kongerige
      • Reading, Det Forenede Kongerige
      • Salford, Det Forenede Kongerige
  • Forenede Stater
    • Arizona
      • Glendale, Arizona, Forenede Stater
      • Phoenix, Arizona, Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater
    • California
      • Carmichael, California, Forenede Stater
      • Citrus Heights, California, Forenede Stater
      • Fair Oaks, California, Forenede Stater
      • Roseville, California, Forenede Stater
      • Sacramento, California, Forenede Stater
      • San Diego, California, Forenede Stater
      • Walnut Creek, California, Forenede Stater
    • Florida
      • Daytona Beach, Florida, Forenede Stater
      • Fleming Island, Florida, Forenede Stater
      • Jacksonville, Florida, Forenede Stater
      • Miami, Florida, Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater
    • Kansas
      • Wichita, Kansas, Forenede Stater
    • Massachusetts
      • Waltham, Massachusetts, Forenede Stater
    • Nevada
      • Pahrump, Nevada, Forenede Stater
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
    • North Carolina
      • Cary, North Carolina, Forenede Stater
      • Charlotte, North Carolina, Forenede Stater
      • Wilmington, North Carolina, Forenede Stater
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater
    • Ohio
      • Franklin, Ohio, Forenede Stater
    • South Carolina
      • Mount Pleasant, South Carolina, Forenede Stater
    • Tennessee
      • Bristol, Tennessee, Forenede Stater
    • Texas
      • Carrollton, Texas, Forenede Stater
      • Dallas, Texas, Forenede Stater
      • Irving, Texas, Forenede Stater
      • Plano, Texas, Forenede Stater
      • Richardson, Texas, Forenede Stater
    • Washington
      • Renton, Washington, Forenede Stater
      • Tacoma, Washington, Forenede Stater
      • Wenatchee, Washington, Forenede Stater
  • Frankrig
      • Corbeil Essonnes, Frankrig
      • Paris, Frankrig
      • Venissieux, Frankrig
  • Grækenland
      • Thessaloniki, Grækenland
      • Thessalonikis, Grækenland
  • Hong Kong
      • Sha Tin, Hong Kong
  • Indien
      • Bangalore, Indien
      • Nagpur, Indien
      • Pune, Indien
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Tauranga, New Zealand
      • Wellington, New Zealand
  • Polen
      • Katowice, Polen
      • Krakow, Polen
      • Torun, Polen
      • Warszawa, Polen
      • Wroclaw, Polen
  • Rumænien
      • Bucharest, Rumænien
      • Sibiu, Rumænien
  • Schweiz
      • Bruderholz, Schweiz
      • St Gallen, Schweiz
  • Spanien
      • Granada, Spanien
      • Madrid, Spanien
      • Pozuelo De Alarcon, Spanien
      • Sevilla, Spanien
  • Sverige
      • Göteborg, Sverige
      • Uppsala, Sverige
  • Sydafrika
      • Pretoria, Sydafrika
  • Ukraine
      • Kharkov, Ukraine
      • Kiev, Ukraine

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

55 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 and may be currently treated with a stable regimen of antihyperglycemic agent(s)
  • Patients in the study must have a HbA1c between >=7 and <=10.0%
  • Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

Exclusion Criteria:

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or 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 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Medicin: Canagliflozin 100 mg
One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Medicin: Antihyperglycemic agent(s)
Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4] inhibitors, metformin, insulin [all types]) and their combinations (sulfonylurea agent and insulin [all types], metformin and insulin [all types], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4]) are used as per protocol specifications.
Eksperimentel: Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Medicin: Antihyperglycemic agent(s)
Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4] inhibitors, metformin, insulin [all types]) and their combinations (sulfonylurea agent and insulin [all types], metformin and insulin [all types], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4]) are used as per protocol specifications.
Medicin: Canagliflozin 300 mg
One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Placebo komparator: Placebo
Each patient will receive matching placebo once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Medicin: Antihyperglycemic agent(s)
Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4] inhibitors, metformin, insulin [all types]) and their combinations (sulfonylurea agent and insulin [all types], metformin and insulin [all types], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4]) are used as per protocol specifications.
Medicin: Placebo
One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring i HbA1c fra baseline til uge 26
Tidsramme: Dag 1 (basislinje) og uge 26
Tabellen nedenfor viser den gennemsnitlige ændring i mindste kvadraters (LS) i HbA1c fra baseline til uge 26 for hver behandlingsgruppe. De statistiske analyser viser behandlingsforskellene (dvs. hver canagliflozin-gruppe minus placebo) i LS-gennemsnitsændringen.
Dag 1 (basislinje) og uge 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring i fastende plasmaglukose (FPG) fra baseline til uge 26
Tidsramme: Dag 1 (basislinje) og uge 26
Tabellen nedenfor viser gennemsnitsændringen i mindste kvadraters (LS) i FPG fra baseline til uge 26 for hver behandlingsgruppe. De statistiske analyser viser behandlingsforskellene (dvs. hver canagliflozin-gruppe minus placebo) i LS-gennemsnitsændringen.
Dag 1 (basislinje) og uge 26
Ændring i systolisk blodtryk (SBP) fra baseline til uge 26
Tidsramme: Dag 1 (basislinje) og uge 26
Tabellen nedenfor viser den gennemsnitlige ændring i mindste kvadraters (LS) i SBP fra baseline til uge 26 for hver behandlingsgruppe. De statistiske analyser viser behandlingsforskellene (dvs. hver canagliflozin-gruppe minus placebo) i LS-gennemsnitsændringen.
Dag 1 (basislinje) og uge 26
Procentdel af patienter med HbA1c <7 % i uge 26
Tidsramme: Uge 26
Tabellen nedenfor viser procentdelen af ​​patienter med HbA1c <7 % i uge 26 i hver behandlingsgruppe. De statistiske analyser viser behandlingsforskellene (dvs. hver canagliflozingruppe minus placebo) i procentdelen.
Uge 26
Percent Change in Body Weight From Baseline to Week 26
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 change.
Day 1 (Baseline) and Week 26
Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. 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 Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Tidsramme: Day 1 (Baseline) and Week 26
Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. 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 Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Tidsramme: Day 1 (Baseline) and Week 26
Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. 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
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 change.
Day 1 (Baseline) and Week 26
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
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 or 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 Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Day 1 (Baseline) and Week 26
Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Day 1 (Baseline) and Week 26
Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Day 1 (Baseline) and Week 26
Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26
Tidsramme: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
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. juni 2010

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

1. april 2010

Først indsendt, der opfyldte QC-kriterier

16. april 2010

Først opslået (Skøn)

20. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR017014
  • 28431754DIA3010 (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 .

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