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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01106651
Registration number
NCT01106651
Ethics application status
Date submitted
1/04/2010
Date registered
20/04/2010
Date last updated
4/11/2014
Titles & IDs
Public title
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
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Scientific title
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
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Secondary ID [1]
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28431754DIA3010
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Secondary ID [2]
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CR017014
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Canagliflozin 100 mg
Treatment: Drugs - Canagliflozin 300 mg
Treatment: Drugs - Antihyperglycemic agent(s)
Treatment: Drugs - Placebo
Experimental: 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.
Experimental: 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.
Placebo Comparator: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in HbA1c From Baseline to Week 26
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Assessment method [1]
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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.
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Timepoint [1]
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Day 1 (Baseline) and Week 26
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Secondary outcome [1]
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Percentage of Patients With HbA1c <7% at Week 26
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Assessment method [1]
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The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
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Timepoint [1]
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Week 26
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Secondary outcome [2]
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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
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Assessment method [2]
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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.
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Timepoint [2]
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Day 1 (Baseline) and Week 26
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Secondary outcome [3]
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Percent Change in Body Weight From Baseline to Week 26
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Assessment method [3]
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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.
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Timepoint [3]
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Day 1 (Baseline) and Week 26
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Secondary outcome [4]
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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
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Assessment method [4]
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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.
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Timepoint [4]
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Day 1 (Baseline) and Week 26
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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Day 1 (Baseline) and Week 26
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Secondary outcome [6]
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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
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Assessment method [6]
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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.
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Timepoint [6]
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Day 1 (Baseline) and Week 26
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Secondary outcome [7]
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Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
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Assessment method [7]
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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.
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Timepoint [7]
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Day 1 (Baseline) and Week 26
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Secondary outcome [8]
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Percent Change in Triglycerides From Baseline to Week 26
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Assessment method [8]
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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.
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Timepoint [8]
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Day 1 (Baseline) and Week 26
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Secondary outcome [9]
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Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
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Assessment method [9]
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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.
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Timepoint [9]
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Day 1 (Baseline) and Week 26
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Secondary outcome [10]
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Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26
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Assessment method [10]
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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.
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Timepoint [10]
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Day 1 (Baseline) and Week 26
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Secondary outcome [11]
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Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26
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Assessment method [11]
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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.
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Timepoint [11]
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Day 1 (Baseline) and Week 26
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Secondary outcome [12]
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Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26
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Assessment method [12]
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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.
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Timepoint [12]
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Day 1 (Baseline) and Week 26
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Secondary outcome [13]
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Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26
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Assessment method [13]
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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.
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Timepoint [13]
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Day 1 (Baseline) and Week 26
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Eligibility
Key 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)
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Minimum age
55
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2013
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Sample size
Target
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Accrual to date
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Final
716
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Fremantle
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Recruitment hospital [2]
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- Heidelberg Heights
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Recruitment hospital [3]
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- Meadowbrook
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Recruitment hospital [4]
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- Richmond
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Recruitment postcode(s) [1]
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- Fremantle
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Recruitment postcode(s) [2]
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- Heidelberg Heights
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Recruitment postcode(s) [3]
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- Meadowbrook
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Recruitment postcode(s) [4]
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- Richmond
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Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Florida
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Georgia
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Kansas
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Massachusetts
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North Carolina
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North Dakota
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Ohio
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Tennessee
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British Columbia
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Colombia
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Barranquilla
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Bogota
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Corbeil Essonnes
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France
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Paris
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France
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Venissieux
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Greece
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Greece
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Thessaloniki
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Hong Kong
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Sha Tin
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India
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Bangalore
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India
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Nagpur
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Pune
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Auckland
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Christchurch
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Tauranga
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New Zealand
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Wellington
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Katowice
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Torun
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Warszawa
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Romania
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Bucharest
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Romania
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Sibiu
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Pretoria
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Madrid
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Pozuelo De Alarcon
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Spain
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Sevilla
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Göteborg
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Uppsala
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Switzerland
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Bruderholz
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Switzerland
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St Gallen
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Ukraine
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Kharkov
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Ukraine
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Kiev
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United Kingdom
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Birmingham
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Liverpool
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Manchester
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Reading
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United Kingdom
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01106651
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01106651
Download to PDF