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
NCT ID: NCT01381900
Last Updated: 2014-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
678 participants
INTERVENTIONAL
2011-08-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Canagliflozin 100mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Canagliflozin 100mg
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).
Metformin
The participant's stable dose of background therapy of metformin should be continued throughout the study.
Sulphonylurea
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Canagliflozin 300mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Canagliflozin 300mg
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).
Metformin
The participant's stable dose of background therapy of metformin should be continued throughout the study.
Sulphonylurea
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Placebo
Each participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Placebo
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).
Metformin
The participant's stable dose of background therapy of metformin should be continued throughout the study.
Sulphonylurea
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Interventions
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Placebo
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).
Canagliflozin 100mg
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).
Canagliflozin 300mg
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).
Metformin
The participant's stable dose of background therapy of metformin should be continued throughout the study.
Sulphonylurea
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Baotou, , China
Beijing, , China
Changchun, , China
Changsha, , China
Chengdu, , China
Chongqing, , China
Guangzhou, , China
Hangzhou, , China
Harbin, , China
Nanchang, , China
Nanjing, , China
Nanning, , China
Shanghai, , China
Shenyang, , China
Shiyan, , China
Siping, , China
Suzhou, , China
Tianjin, , China
Wuxi, , China
Xi'an, , China
Kota Bharu, , Malaysia
Kuala Selangor, , Malaysia
Pulau Pinang, , Malaysia
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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28431754DIA3014
Identifier Type: OTHER
Identifier Source: secondary_id
CR018541
Identifier Type: -
Identifier Source: org_study_id
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