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A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea

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ClinicalTrials.gov Identifier: NCT01381900
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : January 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Placebo
Drug: Canagliflozin 100mg
Drug: Canagliflozin 300mg
Drug: Metformin
Drug: Sulphonylurea

  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 Asian participants with type 2 diabetes mellitus who had inadequate glycemic control on a maximally effective or tolerated dose of metformin alone or metformin plus sulphonylurea (SU). It was conducted between 30 June 2011 and 21 December 2012 and recruited patients from 36 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study had two background treatment strata: 331 participants in the metformin alone stratum and 347 in the metformin plus SU. In total, 678 participants were randomly allocated to the 3 treatment arms, 676 received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and the safety analysis set.

Reporting Groups
  Description
Placebo Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Canagliflozin 100 mg Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Canagliflozin 300 mg Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.

Participant Flow:   Overall Study
    Placebo   Canagliflozin 100 mg   Canagliflozin 300 mg
STARTED   226   223   227 
COMPLETED   217   214   215 
NOT COMPLETED   9   9   12 
Subject meets glycemic withdrawal crit.                2                0                0 
Adverse Event                4                6                7 
Noncompliance with study drug                0                0                1 
Physician Decision                0                1                1 
Protocol Violation                0                1                1 
Withdrawal by Subject                0                0                1 
Early withdraw                3                1                1 



  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 participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Canagliflozin 100 mg Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Canagliflozin 300 mg Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Total Total of all reporting groups

Baseline Measures
   Placebo   Canagliflozin 100 mg   Canagliflozin 300 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 226   223   227   676 
Age 
[Units: Participants]
 		       
<=18 years   0   0   0   0 
Between 18 and 65 years   184   187   186   557 
>=65 years   42   36   41   119 
Age 
[Units: Years]
Mean (Standard Deviation) 		 55.8  (9.35)   56.5  (8.25)   56.4  (9.21)   56.3  (8.94) 
Gender 
[Units: Participants]
 		       
Female   101   99   114   314 
Male   125   124   113   362 
Region Enroll 
[Units: Participants]
 		       
China   213   210   213   636 
Malaysia   3   5   4   12 
Vietnam   10   8   10   28 


  Outcome Measures

1.  Primary:   Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18   [ Time Frame: Day 1 (Baseline) and Week 18 ]
  Show Outcome Measure 1

2.  Secondary:   Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18   [ Time Frame: Day 1 (Baseline) and Week 18 ]
  Show Outcome Measure 2

3.  Secondary:   Percent Change in Body Weight From Baseline to Week 18   [ Time Frame: Day 1 (Baseline) and Week 18 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18   [ Time Frame: Day 1 (Baseline) and Week 18 ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18   [ Time Frame: Day 1 (Baseline) and Week 18 ]
  Show Outcome Measure 5


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information