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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT01381900

First received: June 23, 2011

Last updated: April 23, 2014

Last verified: April 2014

History of Changes

Results First Received: November 21, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (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

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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

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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.
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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

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1. Primary:

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

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2. Secondary:

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18 [ Time Frame: Day 1 (Baseline) and Week 18 ]

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3. Secondary:

Percent Change in Body Weight From Baseline to Week 18 [ Time Frame: Day 1 (Baseline) and Week 18 ]

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4. Secondary:

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

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5. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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