Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01106651
First received: April 1, 2010
Last updated: October 27, 2014
Last verified: October 2014
Results First Received: April 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Canagliflozin 100 mg
Drug: Canagliflozin 300 mg
Drug: Antihyperglycemic agent(s)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
716 patients were randomly allocated to the 3 treatment arms. 714 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented for Baseline to Week 104 (Overall Study).

Reporting Groups
  Description
Placebo Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.

Participant Flow:   Overall Study
    Placebo   Canagliflozin 100 mg   Canagliflozin 300 mg
STARTED   237   241   236 
COMPLETED   158   184   178 
NOT COMPLETED   79   57   58 
Adverse Event                17                9                23 
Lost to Follow-up                8                2                6 
Physician Decision                4                3                1 
Protocol Violation                1                2                1 
Withdrawal by Subject                14                7                4 
Noncompliance with study drug                1                0                2 
Not specified                34                31                21 
Death                0                3                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Total Total of all reporting groups

Baseline Measures
   Placebo   Canagliflozin 100 mg   Canagliflozin 300 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 237   241   236   714 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   151   141   149   441 
>=65 years   86   100   87   273 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.2  (6.21)   64.3  (6.46)   63.4  (5.99)   63.6  (6.24) 
Gender 
[Units: Participants]
       
Female   94   117   107   318 
Male   143   124   129   396 
Region of Enrollment 
[Units: Participants]
       
AUSTRALIA   6   6   11   23 
CANADA   24   32   28   84 
COLOMBIA   18   15   20   53 
FRANCE   2   2   3   7 
GREECE   1   1   1   3 
HONG KONG   1   1   2   4 
INDIA   8   3   11   22 
NEW ZEALAND   16   10   11   37 
POLAND   11   12   14   37 
ROMANIA   8   10   7   25 
SOUTH AFRICA   9   12   10   31 
SPAIN   2   3   8   13 
SWEDEN   4   4   2   10 
SWITZERLAND   2   2   0   4 
UKRAINE   3   8   3   14 
UNITED KINGDOM   19   22   8   49 
UNITED STATES   103   98   97   298 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

2.  Secondary:   Percentage of Patients With HbA1c <7% at Week 26   [ Time Frame: Week 26 ]

3.  Secondary:   Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

4.  Secondary:   Percent Change in Body Weight From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

5.  Secondary:   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   [ Time Frame: Day 1 (Baseline) and Week 26 ]

6.  Secondary:   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   [ Time Frame: Day 1 (Baseline) and Week 26 ]

7.  Secondary:   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   [ Time Frame: Day 1 (Baseline) and Week 26 ]

8.  Secondary:   Change in Systolic Blood Pressure (SBP) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

9.  Secondary:   Percent Change in Triglycerides From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

10.  Secondary:   Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

11.  Secondary:   Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

12.  Secondary:   Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

13.  Secondary:   Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

14.  Secondary:   Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame Adverse event data was collected for the duration of the study (104 weeks).
Additional Description The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.0 used for Week 26 results/ MEDDRA 16.0 used for Week 104 results.

Reporting Groups
  Description
Placebo: Baseline to Week 26 Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
Canagliflozin 100 mg: Baseline to Week 26 Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
Canagliflozin 300 mg: Baseline to Week 26 Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
Placebo: Baseline to Week 104 Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104.
Canagliflozin 100 mg: Baseline to Week 104 Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
Canagliflozin 300 mg: Baseline to Week 104 Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104

Serious Adverse Events
    Placebo: Baseline to Week 26   Canagliflozin 100 mg: Baseline to Week 26   Canagliflozin 300 mg: Baseline to Week 26   Placebo: Baseline to Week 104   Canagliflozin 100 mg: Baseline to Week 104   Canagliflozin 300 mg: Baseline to Week 104
Total, serious adverse events             
# participants affected / at risk   12/237 (5.06%)   10/241 (4.15%)   8/236 (3.39%)   41/237 (17.30%)   40/241 (16.60%)   43/236 (18.22%) 
Cardiac disorders             
Angina pectoris * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   1/237 (0.42%)   1/241 (0.41%)   0/236 (0.00%) 
Atrial fibrillation * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   2/237 (0.84%)   1/241 (0.41%)   3/236 (1.27%) 
Bradycardia * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Cardiac failure congestive * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Coronary artery disease * 1             
# participants affected / at risk   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%)   3/237 (1.27%)   3/241 (1.24%)   3/236 (1.27%) 
Myocardial infarction * 1             
# participants affected / at risk   2/237 (0.84%)   0/241 (0.00%)   1/236 (0.42%)   2/237 (0.84%)   1/241 (0.41%)   2/236 (0.85%) 
Myocarditis * 1             
# participants affected / at risk   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Acute myocardial infarction * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   2/236 (0.85%) 
Angina unstable * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   2/237 (0.84%)   0/241 (0.00%)   2/236 (0.85%) 
Intracardiac thrombus * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Sick sinus syndrome * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Eye disorders             
Diplopia * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%) 
Gastrointestinal disorders             
Haematochezia * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Intestinal infarction * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Umbilical hernia, obstructive * 1             
# participants affected / at risk   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Abdominal hernia obstructive * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Abdominal pain upper * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Colitis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Gastrointestinal angiodysplasia haemorrhagic * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Gastrointestinal haemorrhage * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Gastrooesophageal reflux disease * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Inguinal hernia, obstructive * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Intestinal obstruction * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   1/241 (0.41%)   1/236 (0.42%) 
Lower gastrointestinal haemorrhage * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   2/236 (0.85%) 
Pancreatitis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Pouchitis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Small intestinal obstruction * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
General disorders             
Non-cardiac chest pain * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   2/237 (0.84%)   1/241 (0.41%)   0/236 (0.00%) 
Hepatobiliary disorders             
Bile duct obstruction * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Cholecystitis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   1/241 (0.41%)   0/236 (0.00%) 
Cholecystitis acute * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Cholelithiasis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Immune system disorders             
Drug hypersensitivity * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Infections and infestations             
Pneumonia * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   2/236 (0.85%)   2/237 (0.84%)   0/241 (0.00%)   3/236 (1.27%) 
Urinary tract infection * 1             
# participants affected / at risk   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   1/241 (0.41%)   0/236 (0.00%) 
Urosepsis * 1             
# participants affected / at risk   2/237 (0.84%)   0/241 (0.00%)   0/236 (0.00%)   2/237 (0.84%)   0/241 (0.00%)   0/236 (0.00%) 
Appendicitis perforated * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Cholecystitis infective * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   2/241 (0.83%)   0/236 (0.00%) 
Gastroenteritis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Otitis media * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Sepsis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   1/236 (0.42%) 
Subcutaneous abscess * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Injury, poisoning and procedural complications             
Ankle fracture * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   2/241 (0.83%)   0/236 (0.00%) 
Cervical vertebral fracture * 1             
# participants affected / at risk   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Hand fracture * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Hip fracture * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Joint dislocation * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Laceration * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Meniscus injury * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Muscle rupture * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Procedural pain * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Investigations             
Blood pressure increased * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Metabolism and nutrition disorders             
Hypoglycaemia * 1             
# participants affected / at risk   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Diabetic ketoacidosis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Musculoskeletal and connective tissue disorders             
Osteoarthritis * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   1/237 (0.42%)   1/241 (0.41%)   2/236 (0.85%) 
Cartilage atrophy * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Cervical spinal stenosis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Foot deformity * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Muscular weakness * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Musculoskeletal chest pain * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   1/241 (0.41%)   0/236 (0.00%) 
Spinal column stenosis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Bronchioloalveolar carcinoma * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Metastases to central nervous system * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Prostate cancer * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   2/241 (0.83%)   0/236 (0.00%) 
Squamous cell carcinoma * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Adrenal adenoma * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Angiosarcoma * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Benign salivary gland neoplasm * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Breast cancer * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   2/236 (0.85%) 
Colon cancer * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Hodgkin's disease * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Papillary thyroid cancer * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   2/236 (0.85%) 
Thyroid neoplasm * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Nervous system disorders             
Carotid artery stenosis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Cerebrovascular accident * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   3/241 (1.24%)   1/236 (0.42%) 
Presyncope * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Cauda equina syndrome * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Hepatic encephalopathy * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Hypoaesthesia * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Hypoglycaemic coma * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Hypoglycaemic seizure * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Loss of consciousness * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Migraine with aura * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Syncope * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Transient ischaemic attack * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Psychiatric disorders             
Post-traumatic stress disorder * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Renal and urinary disorders             
Renal colic * 1             
# participants affected / at risk   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%)   2/237 (0.84%)   0/241 (0.00%)   0/236 (0.00%) 
Renal impairment * 1             
# participants affected / at risk   1/237 (0.42%)   0/241 (0.00%)   1/236 (0.42%)   1/237 (0.42%)   0/241 (0.00%)   1/236 (0.42%) 
Calculus ureteric * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Nephrolithiasis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   3/241 (1.24%)   1/236 (0.42%) 
Reproductive system and breast disorders             
Balanoposthitis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Benign prostatic hyperplasia * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Genital prolapse * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   2/241 (0.83%)   0/236 (0.00%) 
Respiratory failure * 1             
# participants affected / at risk   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Asthma * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Hypoventilation * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Nasal septum deviation * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Pulmonary embolism * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Pulmonary fibrosis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   1/237 (0.42%)   0/241 (0.00%)   0/236 (0.00%) 
Sinus polyp * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Skin and subcutaneous tissue disorders             
Psoriasis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Vascular disorders             
Deep vein thrombosis * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Embolism arterial * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   1/241 (0.41%)   0/236 (0.00%) 
Haematoma * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
Peripheral vascular disorder * 1             
# participants affected / at risk   0/237 (0.00%)   0/241 (0.00%)   0/236 (0.00%)   0/237 (0.00%)   0/241 (0.00%)   1/236 (0.42%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MEDDRA 14.0 / 16.0




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01106651     History of Changes
Other Study ID Numbers: CR017014
28431754DIA3010 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: April 1, 2010
Results First Received: April 1, 2013
Last Updated: October 27, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Ukraine: State Pharmacological Center - Ministry of Health