An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
NCT ID: NCT01340664
Last Updated: 2014-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
279 participants
INTERVENTIONAL
2011-07-31
2012-04-30
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
QUADRUPLE
Study Groups
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Canagliflozin 50 mg bid
Each patient will receive 50 mg canagliflozin twice daily for 18 weeks.
Canagliflozin 50 mg
One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks
Metformin
The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Canagliflozin 150 mg bid
Each patient will receive 150 mg canagliflozin twice daily for 18 weeks
Canagliflozin 150 mg
1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks
Metformin
The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Placebo
Each patient will receive matching placebo twice daily for 18 weeks
Placebo
1 placebo capsule taken orally twice daily with a meal for 18 weeks
Metformin
The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Interventions
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Canagliflozin 50 mg
One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks
Placebo
1 placebo capsule taken orally twice daily with a meal for 18 weeks
Canagliflozin 150 mg
1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks
Metformin
The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Eligibility Criteria
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Inclusion Criteria
* Patients in the study must have a HbA1c between \>=7 and \<=10.5%
* Patients must have a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)
Exclusion Criteria
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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Little Rock, Arkansas, United States
National City, California, United States
Spring Valley, California, United States
Bradenton, Florida, United States
Marianna, Florida, United States
Savannah, Georgia, United States
Avon, Indiana, United States
Valparaiso, Indiana, United States
Madisonville, Kentucky, United States
Metairie, Louisiana, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Mason, Ohio, United States
Perrysburg, Ohio, United States
Tulsa, Oklahoma, United States
Yukon, Oklahoma, United States
Oregon City, Oregon, United States
Pittsburgh, Pennsylvania, United States
East Providence, Rhode Island, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Pearland, Texas, United States
San Antonio, Texas, United States
Bountiful, Utah, United States
Virginia Beach, Virginia, United States
Milwaukee, Wisconsin, United States
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Brampton, Ontario, Canada
Toronto, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Beroun, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Písek, , Czechia
Prague, , Czechia
Znojmo, , Czechia
Aguascalientes, , Mexico
Guadalajara, Jalisco., , Mexico
Monterrey, , Mexico
Tampico, , Mexico
Bacau, , Romania
Brasov, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Galati, , Romania
Târgu Mureş, , Romania
Kursk, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Saratov, , Russia
Tyumen, , Russia
Voronezh, , Russia
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Prešov, , Slovakia
Šahy, , Slovakia
Trebišov, , Slovakia
Countries
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References
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Qiu R, Capuano G, Meininger G. Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus. J Clin Transl Endocrinol. 2014 May 5;1(2):54-60. doi: 10.1016/j.jcte.2014.04.001. eCollection 2014 Jun.
Other Identifiers
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28431754DIA2003
Identifier Type: OTHER
Identifier Source: secondary_id
2010-024256-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR017914
Identifier Type: -
Identifier Source: org_study_id
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