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CTRI Number  CTRI/2010/091/001361 [Registered on: 29/09/2010]
Last Modified On: 03/07/2014
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 patients with type 2 diabetes mellitus who are receiving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control. 
Scientific Title of Study
Modification(s)  		 A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
28431754DIA3012 version INT-1 dated 14 JULY 2010  Protocol Number 
NCT01106690  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Jitendra R Dixit 
Designation  Head Global Clinical Operations India 
Affiliation  Johnson and Johnson Limited 
Address  Global Clinical Operations, Johnson & Johnson Limited, 9-sigma, Hiranandani Gardens, Powai, Mumbai 400076
Johnson & Johnson Limited 30 Forjett Street Mumbai 400 036
Mumbai
MAHARASHTRA
400076
India 
Phone  919167068006  
Fax  02225701333  
Email  jdixit@its.jnj.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Jitendra R Dixit 
Designation  Head Global Clinical Operations India 
Affiliation  Johnson & Johnson Limited 
Address  Johnson & Johnson Ltd Global Clinical Operations 9th Floor, Sigma, Hiranandani Gardens, Powai
Johnson & Johnson Limited
Mumbai
MAHARASHTRA
400076
India 
Phone  919167068006  
Fax  02225701333  
Email  mgupta1@its.jnj.com  
 
Source of Monetary or Material Support
Modification(s)  
Johnson & Johnson Pharmaceutical Research & Development, L.L.C Global Communications Mailstop E1756 920 Route 202 Raritan, NJ 08869 USA  
 
Primary Sponsor
Modification(s)  
Name  Johnson Johnson Pharmaceutical Research Development LLC  
Address  Global Communications Mailstop E1756 920 Route 202 Raritan, NJ 08869 USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment
Modification(s)  		   India
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Shriraam Mahadevan  Associates in Clinical Endocrinology Education and Research (ACEER)  7/12, 15th Cross Street,Sastri Nagar, Adyar-600 020
Chennai
TAMIL NADU 		 +91 44 24460762
+91 44 24460760
aceer.dia3012@gmail.com 
Dr Neeta Deshpande  Belgaum Diabetes Center  Ground and Second floor, Maruti Gali, Belgaum
Belgaum
KARNATAKA 		 918314215380

neetarohit@gmail.com 
Dr. Rakesh Parikh  D Clinarch(Diamed Clinical Research Services Pvt.Ltd)  C 56,Ram Nagar,Shastri Nagar-302016
Jaipur
RAJASTHAN 		 +919351384427
+911412303411
drrakeshparikh@gmail.com 
Dr. Urman Dhruv  HCG Medi-Surge Hosptials  1, Maharashtra Society, Near Mithakhali Six Roads, ,Ellisbridge-380006
Ahmadabad
GUJARAT 		 91-9327020958
+917926441401
drurmandhruv@hotmail.com 
Dr Girithara Gopalakrishnan  K.G Hospital and Post graduate medical institute  ground floor , K.G Hospital Arts College Road,-641018
Coimbatore
TAMIL NADU 		 919443170088
914222212121
drgirimd@yahoo.com 
Dr Sunil Gupta  Sunil’s Diabetes Care & Research Centre Pvt Ltd  42 Lendra Park, Nagpur
Nagpur
MAHARASHTRA 		 9823152111

drsgupta_ngp@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
CLINICOM  Approved 
Ethics committee of Diabetes care n research centre  Approved 
HCG Medi-Surge Ethics Committee  Approved 
National Ethics Committee  Approved 
Regional Ethics Committee  Approved 
Swasthya Kalyan Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Diabetes Mellitus, Type 2 ,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Canagliflozin  100 mg oral capsule once daily for 52 weeks with stable doses of metformin and pioglitazone 
Intervention  Canagliflozin  300 mg oral capsule once daily for 52 weeks with stable doses of metformin and pioglitazone.  
Comparator Agent  Placebo/sitaliptin 100 mg   1 placebo oral capsule once daily for 26 weeks with stable doses of metformin and pioglitazone, then crossover to sitagliptin one 100 mg capsule once daily beginning at Week 26 for 26 weeks with stable doses of metformin and pioglitazone.  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients must have a diagnosis of T2DM and be currently treated with PPAR gamma agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin)
Patients in the study must have a HbA1c between more than or equal to 7 and less than or equal to 10.5% and 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   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
The effect of canagliflozin relative to placebo on the change from baseline in hemoglobin A1c (HbA1c).   After 26 weeks of treatment with study drug 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To assess the effect of study drug on systolic and diastolic blood pressure and body weight   After 26 and 52 weeks of treatment  
To assess the effect of study drug on time to rescue therapy and proportion of patients requiring rescue therapy   After 26 and 52 weeks of treatment  
To assess the effect of study drug on change from baseline in HbA1c   After 52 weeks of treatment  
To assess the effect of study drug on change from baseline in fasting plasma glucose (FPG), fasting plasma lipids, and beta-cell function  After 26 and 52 weeks of treatment  
To assess the effect of study drug on the proportion of patients achieving an HbA1c <7 and <6.5%   After 26 and 52 weeks of treatment  
 
Target Sample Size
Modification(s)  		 Total Sample Size="360"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  		 Phase 3 
Date of First Enrollment (India)
Modification(s)  		 13/12/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  13/04/2010 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="2"
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), 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 with metformin and pioglitazone to control their diabetes. Approximately 360 patients with T2DM who are receiving combination therapy with metformin and pioglitazone will receive the addition of once-daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 26 weeks followed by a 26-week extension period where patients treated with canagliflozin (100 mg or 300 mg) will continue treatment for an additional 26 weeks and patients treated with placebo will be switched to active double-blind treatment with sitagliptin 100 mg, an antihyperglycemic agent administered once-daily for 26 weeks. In addition, all patients will take protocol specified stable doses of metformin and pioglitazone along with assigned study drug for the duration of the study. Patients will participate in the study for approximately 59 to 78 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with glimepiride (rescue therapy) in accordance with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 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. 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) for 52 weeks OR placebo for 26 weeks switched to double-blind sitagliptin 100 mg for 26 weeks. We expect to randomize 50 patients from India. The estimated first patient consented date is 4 October 2010. 
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