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CTRI Number  CTRI/2010/091/002997 [Registered on: 25/11/2010]
Last Modified On: 10/10/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  		 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.  
Scientific Title of Study
Modification(s)  		 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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
28431754DIA3010  Protocol Number 
NCT01106651  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  NA 
Designation   
Affiliation   
Address  NA

Meerut
UTTAR PRADESH
NA
India 
Phone    
Fax    
Email  NA@its.jnj.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Jitendra Dixit 
Designation  Head Global Clinical Operations India 
Affiliation  Johnson and Johnson Ltd 
Address  Global Clinical Operations Johnson and Johnson Ltd 9th Floor Sigma Hiranandani Gardens Powai

Mumbai
MAHARASHTRA
400076
India 
Phone  9167068006  
Fax  02225701333  
Email  jdixit@its.jnj.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Jitendra Dixit 
Designation  Head Global Clinical Operations India 
Affiliation   
Address  Global Clinical Operations Johnson and Johnson Ltd 9th Floor Sigma Hiranandani Gardens Powai

Mumbai
MAHARASHTRA
400076
India 
Phone  022-25715555  
Fax  022-25701333  
Email  jdixit@its.jnj.com  
 
Source of Monetary or Material Support
Modification(s)  
Janssen Research & Development, L.L.C. 
 
Primary Sponsor
Modification(s)  
Name  Johnson Johnson Ltd  
Address  Global Clinical Operations Johnson and Johnson Ltd 9th Floor Sigma Hiranandani Gardens Powai 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Johnson and Johnson Ltd  30 Forjett Street Mumbai 400036 
 
Countries of Recruitment
Modification(s)  		   Australia
Brazil
Canada
Colombia
Estonia
France
Greece
India
New Zealand
Other
Poland
Romania
South Africa
Spain
Sweden
Switzerland
Ukraine
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Aravind Sosale  Diacon Hospital, Diabetes Care and Research Centre  # 359-360, 19th Main Road,,1st Block, Rajajinagar-560010

 		 080-23131166
080-23130553
diacon90@hotmail.com 
Dr. Jayashri Shembalkar  Get Well Hospital and Research Institute  20/1, Khare Marg, Behind Vijayanand Society,Dhantoli-440012
Nagpur
MAHARASHTRA 		 9665013901
0712-6645017
pkshembalkar@hotmail.com 
Dr Uday Phadke  Instride  6,POONAM ARCADE,1170/11, ,REVENUE COLONY, JM ROAD, SHIVAJINAGAR-411005
Pune
MAHARASHTRA 		 020-25521833
020-25530899
uday.instride@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Diacon Hospital Ethics Committee  Approved 
Ethics Committee Instride  Approved 
Global Health Concern Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus Patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Canagliflozin 100 mg   300 mg capsule once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry. 
Intervention  Canagliflozin 300 mg  300 mg capsule OD for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry. 
Comparator Agent  Placebo   1 placebo capsule OD for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.  
 
Inclusion Criteria
Modification(s)  
Age From  55.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult Male or females aged between 55 to 80 years of age with 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 greater ot equal to 7 and less than or equal to 10 percent.
Patients must have a fasting plasma glucose (FPG) less than 270 mg/dL (15 mmol/L)
 
 
ExclusionCriteria 
Details  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  
 
Method of Generating Random Sequence
Modification(s)  		 Computer generated randomization 
Method of Concealment
Modification(s)  		 Centralized 
Blinding/Masking
Modification(s)  		 Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) in the main study.  After 26 weeks of treatment with study drug 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of study drug on bone mineral density as measured by dual-energy X-ray absorptiometry (DXA)   After 26, 52 and 104 weeks of treatment with study drug 
To assess the effect of study drug on bone strength as measured by Quantitative Computerized Tomography (QCT) in a subgroup of patients   After 52 weeks of treatment  
To assess the effect of study drug on markers of bone turnover   After 12 and 26 weeks of treatment  
To assess the effect of study drug on body composition (eg total fat mass) as measured by DXA   After 26 weeks of treatment  
 
Target Sample Size
Modification(s)  		 Total Sample Size="720"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 15/11/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  03/05/2010 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 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. We expect to randomize 60 patients from India and we expect to consent first patient on 15 November 2010. 
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