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CompletedNCT01106651Updated Nov 4, 2014Results posted

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

A Phase 3 interventional study of Canagliflozin 100 mg and Canagliflozin 300 mg in Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development, LLC. Completed at 86 sites in 17 countries. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-11-04.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
716
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Canagliflozin
  • Placebo
  • Hemoglobin A1c
  • Bone
  • Type 2 diabetes mellitus
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 716 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.

Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
716 participants (actual)

Study arms

  • 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.

    Drug: Canagliflozin 100 mg · Drug: Antihyperglycemic agent(s)

  • 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.

    Drug: Canagliflozin 300 mg · Drug: Antihyperglycemic agent(s)

  • 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.

    Drug: Antihyperglycemic agent(s) · Drug: Placebo

Interventions

  • DrugCanagliflozin 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.

  • DrugCanagliflozin 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.

  • DrugAntihyperglycemic 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.

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Change in HbA1c From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

Secondary outcomes

  1. Percentage of Patients With HbA1c <7% at Week 26

    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.

    Time frame: Week 26

  2. Change in Fasting Plasma Glucose (FPG) From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

  3. Percent Change in Body Weight From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

  4. 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

    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.

    Time frame: Day 1 (Baseline) and Week 26

  5. 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

    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.

    Time frame: Day 1 (Baseline) and Week 26

  6. 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

    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.

    Time frame: Day 1 (Baseline) and Week 26

  7. Change in Systolic Blood Pressure (SBP) From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

  8. Percent Change in Triglycerides From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

  9. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

  10. Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

  11. Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

  12. Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

  13. Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

07

Results

Posted May 29, 2013

Participant flow

This study evaluated the efficacy and safety of canagliflozin in older patients with type 2 diabetes mellitus with inadequate control on their current diabetes treatment regimen. The study began on 07 June 2010 and ended on 23 May 2013. Patients were recruited from 90 study centers located in 17 countries worldwide.

Participant flow — Overall Study
MilestonePlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Started237241236
Completed158184178
Not completed795758
Withdrew: Adverse event17923
Withdrew: Lost to follow-up826
Withdrew: Physician decision431
Withdrew: Protocol violation121
Withdrew: Withdrawal by subject1474
Withdrew: Noncompliance with study drug102
Withdrew: Other343121
Withdrew: Death030

Outcome measures

PrimaryChange in HbA1c From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent
Change in HbA1c From Baseline to Week 26
PercentPlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Change in HbA1c From Baseline to Week 26-0.03 ± 0.063-0.60 ± 0.063-0.73 ± 0.064
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -0.57 · 95% CI -0.708 to -0.436
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -0.70 · 95% CI -0.841 to -0.566
SecondaryPercentage of Patients With HbA1c <7% at Week 26

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.

Time frame:
Week 26
Reported as:
Number · Percentage of patients
Percentage of Patients With HbA1c <7% at Week 26
Percentage of patientsPlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Percentage of Patients With HbA1c <7% at Week 2628.047.758.5
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · Regression, Logistic · p = <0.001 · Odds ratio (or): 2.96 · 95% CI 1.93 to 4.56
  • Placebo vs Canagliflozin 300 mg · Regression, Logistic · p = <0.001 · Odds ratio (or): 4.48 · 95% CI 2.89 to 6.95
SecondaryChange in Fasting Plasma Glucose (FPG) From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · mg/dL
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
mg/dLPlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 267.39 ± 2.875-18.1 ± 2.860-20.3 ± 2.920
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -25.5 · 95% CI -31.68 to -19.32
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -27.7 · 95% CI -33.97 to -21.49
SecondaryPercent Change in Body Weight From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent change
Percent Change in Body Weight From Baseline to Week 26
Percent changePlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Percent Change in Body Weight From Baseline to Week 26-0.1 ± 0.3-2.4 ± 0.3-3.1 ± 0.3
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -2.3 · 95% CI -2.8 to -1.7
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -3.0 · 95% CI -3.5 to -2.4
SecondaryChange 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

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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · kg
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
kgPlaceboCanagliflozin 100 mgCanagliflozin 300 mg
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-0.28 ± 0.336-1.87 ± 0.332-2.38 ± 0.323
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -1.59 · 95% CI -2.339 to -0.842
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -2.10 · 95% CI -2.833 to -1.368
SecondaryChange 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

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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent
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
PercentPlaceboCanagliflozin 100 mgCanagliflozin 300 mg
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 Composition0.00 ± 0.270-1.03 ± 0.268-1.18 ± 0.261
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -1.03 · 95% CI -1.633 to -0.428
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -1.18 · 95% CI -1.772 to -0.587
SecondaryChange 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

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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent
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
PercentPlaceboCanagliflozin 100 mgCanagliflozin 300 mg
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 Composition0.02 ± 0.280-1.04 ± 0.278-1.18 ± 0.270
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = 0.001 · Least-squares mean difference: -1.05 · 95% CI -1.677 to -0.430
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -1.20 · 95% CI -1.812 to -0.584
SecondaryChange in Systolic Blood Pressure (SBP) From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · mmHg
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
mmHgPlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Change in Systolic Blood Pressure (SBP) From Baseline to Week 261.10 ± 1.039-3.52 ± 1.035-6.79 ± 1.056
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -4.63 · 95% CI -6.854 to -2.401
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -7.89 · 95% CI -10.14 to -5.641
SecondaryPercent Change in Triglycerides From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent change
Percent Change in Triglycerides From Baseline to Week 26
Percent changePlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Percent Change in Triglycerides From Baseline to Week 267.7 ± 3.42.8 ± 3.38.4 ± 3.4
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = 0.194 · Least-squares mean difference: -4.8 · 95% CI -12.1 to 2.5
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = 0.846 · Least-squares mean difference: 0.7 · 95% CI -6.6 to 8.1
SecondaryPercent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent change
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Percent changePlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 261.5 ± 1.26.8 ± 1.26.2 ± 1.2
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = <0.001 · Least-squares mean difference: 5.3 · 95% CI 2.6 to 7.9
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = <0.001 · Least-squares mean difference: 4.7 · 95% CI 2.0 to 7.4
SecondaryPercent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent change
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26
Percent changePlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 260.5 ± 0.30.7 ± 0.30.2 ± 0.3
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · Least-squares mean difference: 0.2 · 95% CI -0.4 to 0.8
  • Placebo vs Canagliflozin 300 mg · ANCOVA · Least-squares mean difference: -0.3 · 95% CI -0.9 to 0.3
SecondaryPercent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent change
Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26
Percent changePlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26-0.5 ± 0.3-0.7 ± 0.3-0.8 ± 0.3
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · Least-squares mean difference: -0.3 · 95% CI -0.9 to 0.4
  • Placebo vs Canagliflozin 300 mg · ANCOVA · Least-squares mean difference: -0.4 · 95% CI -1.0 to 0.3
SecondaryPercent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent change
Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26
Percent changePlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26-1.0 ± 0.3-0.7 ± 0.3-0.6 ± 0.3
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · Least-squares mean difference: 0.3 · 95% CI -0.3 to 1.0
  • Placebo vs Canagliflozin 300 mg · ANCOVA · Least-squares mean difference: 0.4 · 95% CI -0.3 to 1.1
SecondaryPercent Change in Total Hip Bone Mineral Density (BMD) From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · Percent change
Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26
Percent changePlaceboCanagliflozin 100 mgCanagliflozin 300 mg
Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26-0.5 ± 0.2-0.9 ± 0.2-1.0 ± 0.2
Statistical analysis
  • Placebo vs Canagliflozin 100 mg · ANCOVA · Least-squares mean difference: -0.4 · 95% CI -0.8 to -0.0
  • Placebo vs Canagliflozin 300 mg · ANCOVA · Least-squares mean difference: -0.5 · 95% CI -0.9 to -0.1

Adverse events

Collected over Adverse event data was collected for the duration of the study (104 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo: Baseline to Week 26—12/237 (5.1%)99/237 (41.8%)
Canagliflozin 100 mg: Baseline to Week 26—10/241 (4.1%)92/241 (38.2%)
Canagliflozin 300 mg: Baseline to Week 26—8/236 (3.4%)98/236 (41.5%)
Placebo: Baseline to Week 104—41/237 (17.3%)166/237 (70%)
Canagliflozin 100 mg: Baseline to Week 104—40/241 (16.6%)169/241 (70.1%)
Canagliflozin 300 mg: Baseline to Week 104—43/236 (18.2%)169/236 (71.6%)
Most frequent serious events
Showing 10 of 106
Most frequent serious events
EventPlacebo: Baseline to Week 26Canagliflozin 100 mg: Baseline to Week 26Canagliflozin 300 mg: Baseline to Week 26Placebo: Baseline to Week 104Canagliflozin 100 mg: Baseline to Week 104Canagliflozin 300 mg: Baseline to Week 104
Atrial fibrillationCardiac disorders0/2371/2410/2362/2371/2413/236
Coronary artery diseaseCardiac disorders1/2370/2410/2363/2373/2413/236
PneumoniaInfections and infestations0/2370/2412/2362/2370/2413/236
Cerebrovascular accidentNervous system disorders0/2371/2410/2360/2373/2411/236
NephrolithiasisRenal and urinary disorders0/2370/2410/2360/2373/2411/236
Myocardial infarctionCardiac disorders2/2370/2411/2362/2371/2412/236
OsteoarthritisMusculoskeletal and connective tissue disorders0/2371/2410/2361/2371/2412/236
Acute myocardial infarctionCardiac disorders0/2370/2410/2361/2370/2412/236
Angina unstableCardiac disorders0/2370/2410/2362/2370/2412/236
Lower gastrointestinal haemorrhageGastrointestinal disorders0/2370/2410/2360/2370/2412/236
Most frequent other events
Showing 10 of 24
Most frequent other events
EventPlacebo: Baseline to Week 26Canagliflozin 100 mg: Baseline to Week 26Canagliflozin 300 mg: Baseline to Week 26Placebo: Baseline to Week 104Canagliflozin 100 mg: Baseline to Week 104Canagliflozin 300 mg: Baseline to Week 104
HypoglycaemiaMetabolism and nutrition disorders34/23725/24123/23647/23737/24136/236
NasopharyngitisInfections and infestations19/23723/24119/23636/23745/24144/236
Urinary tract infectionInfections and infestations9/23714/24117/23621/23732/24135/236
Upper respiratory tract infectionInfections and infestations11/23713/24110/23629/23723/24125/236
Back painMusculoskeletal and connective tissue disorders8/2376/24112/23619/23724/24128/236
HeadacheNervous system disorders15/2378/24113/23625/23714/24122/236
InfluenzaInfections and infestations5/23714/2419/23618/23725/24118/236
DiarrhoeaGastrointestinal disorders14/23710/24111/23624/23714/24124/236
ArthralgiaMusculoskeletal and connective tissue disorders12/2374/2415/23624/23721/2419/236
CoughRespiratory, thoracic and mediastinal disorders0/2370/2410/23622/23717/24118/236

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PlaceboCanagliflozin 100 mgCanagliflozin 300 mgTotal
<=18 years0000
Between 18 and 65 years151141149441
>=65 years8610087273
Age, Continuous
Age, Continuous(years)PlaceboCanagliflozin 100 mgCanagliflozin 300 mgTotal
Mean63.2 ± 6.2164.3 ± 6.4663.4 ± 5.9963.6 ± 6.24
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboCanagliflozin 100 mgCanagliflozin 300 mgTotal
Female94117107318
Male143124129396
Region of Enrollment
Region of Enrollment(participants)PlaceboCanagliflozin 100 mgCanagliflozin 300 mgTotal
AUSTRALIA661123
CANADA24322884
COLOMBIA18152053
FRANCE2237
GREECE1113
HONG KONG1124
INDIA831122
NEW ZEALAND16101137
POLAND11121437
ROMANIA810725
SOUTH AFRICA9121031
SPAIN23813
SWEDEN44210
SWITZERLAND2204
UKRAINE38314
UNITED KINGDOM1922849
UNITED STATES1039897298
08

Study locations

86 sites
  • Glendale, Arizona, United States
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Carmichael, California, United States
  • Citrus Heights, California, United States
  • Fair Oaks, California, United States
  • Roseville, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Walnut Creek, California, United States
  • Daytona Beach, Florida, United States
  • Fleming Island, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Wichita, Kansas, United States
  • Waltham, Massachusetts, United States
  • Pahrump, Nevada, United States
  • Albuquerque, New Mexico, United States
  • Cary, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Bismarck, North Dakota, United States
  • Franklin, Ohio, United States
  • Mt. Pleasant, South Carolina, United States
  • Bristol, Tennessee, United States
  • Carrollton, Texas, United States
  • Dallas, Texas, United States
  • Irving, Texas, United States
  • Plano, Texas, United States
  • Richardson, Texas, United States
  • Renton, Washington, United States
  • Tacoma, Washington, United States
  • Wenatchee, Washington, United States
  • Fremantle, Australia
  • Heidelberg Heights, Australia
  • Meadowbrook, Australia
  • Richmond, Australia
  • Vancouver, British Columbia, Canada
  • St. John's, Newfoundland and Labrador, Canada
  • Barrie, Ontario, Canada
  • London, Ontario, Canada
  • Markham, Ontario, Canada
  • Oakville, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Barranquilla, Colombia
  • Bogotá, Colombia
  • Corbeil-Essonnes, France
  • Paris, France
  • Vénissieux, France
  • Thessaloniki, Greece
  • Thessalonikis, Greece
  • Shatin, Hong Kong
  • Bangalore, India
  • Nagpur, India
  • Pune, India
  • Auckland, New Zealand
  • Christchurch, New Zealand
  • Tauranga, New Zealand
  • Wellington, New Zealand
  • Katowice, Poland
  • Krakow, Poland
  • Torun, Poland
  • Warsaw, Poland
  • Wroclaw, Poland
  • Bucharest, Romania
  • Sibiu, Romania
  • Pretoria, South Africa
  • Granada, Spain
  • Madrid, Spain
  • Pozuelo de Alarcón, Spain
  • Seville, Spain
  • Gothenburg, Sweden
  • Uppsala, Sweden
  • Bruderholz, Switzerland
  • Sankt Gallen, Switzerland
  • Kharkiv, Ukraine
  • Kiev, Ukraine
  • Birmingham, United Kingdom
  • Cardiff, United Kingdom
  • Glasgow, United Kingdom
  • Liverpool, United Kingdom
  • Manchester, United Kingdom
  • Reading, United Kingdom
  • Salford, United Kingdom
09

References and documents

Publications

  • Januzzi JL Jr, Butler J, Jarolim P, Sattar N, Vijapurkar U, Desai M, Davies MJ. Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes. J Am Coll Cardiol. 2017 Aug 8;70(6):704-712. doi: 10.1016/j.jacc.2017.06.016. Epub 2017 Jun 12. PubMed 28619659 ↗
  • Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4. PubMed 27977934 ↗
  • Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7. PubMed 27002421 ↗
  • Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18. PubMed 26580237 ↗
  • Bilezikian JP, Watts NB, Usiskin K, Polidori D, Fung A, Sullivan D, Rosenthal N. Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin. J Clin Endocrinol Metab. 2016 Jan;101(1):44-51. doi: 10.1210/jc.2015-1860. Epub 2015 Nov 18. PubMed 26580234 ↗
  • Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22. PubMed 24786834 ↗
  • Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21. PubMed 24517339 ↗
  • Bode B, Stenlof K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract (1995). 2013 Apr;41(2):72-84. doi: 10.3810/hp.2013.04.1020. PubMed 23680739 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2010, a primary completion of Nov 2011 and a completion of May 2013. It does not say whether these dates are actual or estimated.

Results were first posted in May 2013, 1 year 6 months after primary completion. A results delay was requested in Mar 2012.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2010
First posted
Apr 20, 2010
Start
Jun 2010
Primary completionActual
Nov 2011
CompletionActual
May 2013
Results delay requested
Mar 30, 2012
Results first posted
May 29, 2013
Last update
Nov 4, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01106651
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Apr 20, 2010
Start date
Jun 2010
Primary completion
Nov 2011
Completion
May 2013
Results posted
May 29, 2013
Last update
Nov 4, 2014

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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