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
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week 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 Alone or in Combination With a Sulphonylurea
2 other identifiers
interventional
678
3 countries
25
Brief Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Aug 2011
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
January 9, 2014
CompletedMay 9, 2014
April 1, 2014
1.3 years
June 23, 2011
November 21, 2013
April 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18
The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 18
Secondary Outcomes (4)
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
Day 1 (Baseline) and Week 18
Percent Change in Body Weight From Baseline to Week 18
Day 1 (Baseline) and Week 18
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18
Day 1 (Baseline) and Week 18
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18
Day 1 (Baseline) and Week 18
Study Arms (3)
Canagliflozin 100mg
EXPERIMENTALEach participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Canagliflozin 300mg
EXPERIMENTALEach participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Placebo
PLACEBO COMPARATOREach participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Interventions
Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
The participant's stable dose of background therapy of metformin should be continued throughout the study.
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Eligibility Criteria
You may qualify if:
- Patients with T2DM with inadequate glycemic control on metformin monotherapy or on metformin in combination with an SU at protocol-specified doses and having HbA1c \>=7.0% and \<=10.5% at Week -2 are eligible for enrollment in the study.
You may not qualify if:
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements \>=270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
- History of a severe hypoglycemic episode within 6 months before screening
- History of or current illness considered to be clinically significant by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Baotou, China
Unknown Facility
Beijing, China
Unknown Facility
Changchun, China
Unknown Facility
Changsha, China
Unknown Facility
Chengdu, China
Unknown Facility
Chongqing, China
Unknown Facility
Guangzhou, China
Unknown Facility
Hangzhou, China
Unknown Facility
Harbin, China
Unknown Facility
Nanchang, China
Unknown Facility
Nanjing, China
Unknown Facility
Nanning, China
Unknown Facility
Shanghai, China
Unknown Facility
Shenyang, China
Unknown Facility
Shiyan, China
Unknown Facility
Siping, China
Unknown Facility
Suzhou, China
Unknown Facility
Tianjin, China
Unknown Facility
Wuxi, China
Unknown Facility
Xi'an, China
Unknown Facility
Kota Bharu, Malaysia
Unknown Facility
Kuala Selangor, Malaysia
Unknown Facility
Pulau Pinang, Malaysia
Unknown Facility
Hanoi, Vietnam
Unknown Facility
Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
August 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
May 9, 2014
Results First Posted
January 9, 2014
Record last verified: 2014-04