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
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Canagliflozin 50 mg Drug: Placebo Drug: Canagliflozin 150 mg Drug: Metformin |
Phase | Phase 2 |
Sponsor | Janssen Research & Development, LLC |
Responsible Party | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier | NCT01340664 |
First Received | April 21, 2011 |
Last Updated | March 5, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | April 21, 2011 |
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Last Updated Date | March 5, 2014 |
Start Date | July 2011 |
Estimated Primary Completion Date | April 2012 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | 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 |
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Official Title | A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter 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 |
Brief Summary | The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control. |
Detailed Description | This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (T2DM) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should remain the same throughout the study. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Canagliflozin 50 mg One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks Drug: Placebo 1 placebo capsule taken orally twice daily with a meal for 18 weeks Drug: Canagliflozin 150 mg 1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks Drug: Metformin The patient's stable daily dose of Metformin background therapy should be continued throughout the study. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 279 |
Estimated Completion Date | April 2012 |
Estimated Primary Completion Date | April 2012 |
Eligibility Criteria | Inclusion Criteria: - All patients must have a diagnosis of T2DM and be currently treated with metformin - 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: - History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Canada, Czech Republic, Mexico, Romania, Russian Federation, Slovakia |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01340664 |
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Other Study ID Numbers | CR017914 |
Has Data Monitoring Committee | Yes |
Information Provided By | Janssen Research & Development, LLC |
Study Sponsor | Janssen Research & Development, LLC |
Collaborators | Not Provided |
Investigators | Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
United States, Arkansas | Little Rock, Arkansas, United States |
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United States, California | National City, California, United States |
United States, California | Spring Valley, California, United States |
United States, Florida | Bradenton, Florida, United States |
United States, Florida | Marianna, Florida, United States |
United States, Georgia | Savannah, Georgia, United States |
United States, Indiana | Avon, Indiana, United States |
United States, Indiana | Valparaiso, Indiana, United States |
United States, Kentucky | Madisonville, Kentucky, United States |
United States, Louisiana | Metairie, Louisiana, United States |
United States, North Carolina | Charlotte, North Carolina, United States |
United States, Ohio | Columbus, Ohio, United States |
United States, Ohio | Mason, Ohio, United States |
United States, Ohio | Perrysburg, Ohio, United States |
United States, Oklahoma | Tulsa, Oklahoma, United States |
United States, Oklahoma | Yukon, Oklahoma, United States |
United States, Oregon | Oregon City, Oregon, United States |
United States, Pennsylvania | Pittsburg, Pennsylvania, United States |
United States, Rhode Island | East Providence, Rhode Island, United States |
United States, Tennessee | Nashville, Tennessee, United States |
United States, Texas | Houston, Texas, United States |
United States, Texas | Pearland, Texas, United States |
United States, Texas | San Antonio, Texas, United States |
United States, Utah | Bountiful, Utah, United States |
United States, Virginia | Virginia Beach, Virginia, United States |
United States, Wisconsin | Milwaukee, Wisconsin, United States |
Canada, Newfoundland and Labrador | St. John'S, Newfoundland and Labrador, Canada |
Canada, Nova Scotia | Halifax, Nova Scotia, Canada |
Canada, Ontario | Brampton, Ontario, Canada |
Canada, Ontario | Toronto, Ontario, Canada |
Canada, Saskatchewan | Saskatoon, Saskatchewan, Canada |
Czech Republic | Beroun, Czech Republic |
Czech Republic | Olomouc 9, Czech Republic |
Czech Republic | Ostrava, Czech Republic |
Czech Republic | Pardubice, Czech Republic |
Czech Republic | Pisek, Czech Republic |
Czech Republic | Prague 10, Czech Republic |
Czech Republic | Praha 11, Czech Republic |
Czech Republic | Znojmo, Czech Republic |
Mexico | Aguascalientes, Mexico |
Mexico | Guadalajara, Jalisco., Mexico |
Mexico | Monterrey, Mexico |
Mexico | Tampico, Mexico |
Romania | Bacau, Romania |
Romania | Brasov, Romania |
Romania | Bucharest, Romania |
Romania | Cluj-Napoca, Romania |
Romania | Galati, Romania |
Romania | Targu Mures, Romania |
Russian Federation | Kursk, Russian Federation |
Russian Federation | Moscow, Russian Federation |
Russian Federation | Saint-Petersburg, Russian Federation |
Russian Federation | Samara, Russian Federation |
Russian Federation | Saratov, Russian Federation |
Russian Federation | St Petersburg, Russian Federation |
Russian Federation | St-Petersburg, Russian Federation |
Russian Federation | Tyumen, Russian Federation |
Russian Federation | Voronezh, Russian Federation |
Slovakia | Banska Bystrica, Slovakia |
Slovakia | Bratislava, Slovakia |
Slovakia | Kosice, Slovakia |
Slovakia | Presov, Slovakia |
Slovakia | Sahy, Slovakia |
Slovakia | Trebisov, Slovakia |