A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Canagliflozin 100 mg Drug: Canagliflozin 300 mg Drug: Metformin XR |
| Phase | Phase 3 |
| Sponsor | Janssen Research & Development, LLC |
| Responsible Party | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier | NCT01809327 |
| First Received | March 8, 2013 |
| Last Updated | April 11, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 8, 2013 |
|---|---|
| Last Updated Date | April 11, 2014 |
| Start Date | June 2013 |
| Estimated Primary Completion Date | December 2014 |
| Current Primary Outcome Measures | Change in glycated hemoglobin (HbA1c) from baseline to Week 26 [Time Frame: Day 1 (Baseline) up to Week 26] [Designated as safety issue: No]The change in HbA1c will be compared between the different treatment groups. |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise |
|---|---|
| Official Title | A Randomized, Double-Blind, 5-Arm, Parallel-Group, 26-Week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in Combination With Metformin as Initial Combination Therapy in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise |
| Brief Summary | The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed. |
| Detailed Description | This study will be a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), active-controlled (one of the treatments is an established effective treatment for type 2 diabetes mellitus), parallel-group (each group of participants will be treated at the same time), 5-arm (groups), multicenter study. Approximately 1,200 participants will be randomly assigned to the 5 treatment arms in a 1:1:1:1:1 ratio for 26 weeks. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| 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 100 mg One 100 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 100 mg arm) or with the evening meal (for the Canagliflozin 100 mg + Metformin XR arm). Drug: Canagliflozin 300 mg One 300 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 300 mg arm) or with the evening meal (for the Canagliflozin 300 mg + Metformin XR arm). Drug: Metformin XR One 500 mg tablet (Day 1 up to week 1); two 500 mg tablets (Week 1 up to Week 3); three 500 mg tablets (Week 3 to Week 6); four 500 mg tablets (Week 6 to Week 9). Tablets will be administered with the evening meal. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 1200 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | May 2014 |
| Eligibility Criteria | Inclusion Criteria: - Must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise - Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7 percent and less than or equal to 12.5 percent - Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory - Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L) prior to randomization - Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L) performed at home or at the study center prior to randomization Exclusion Criteria: - History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy - Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the investigator cannot reasonably exclude T1DM based upon clinical evaluation - Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite reinforcement of diet and exercise counseling - History of hereditary glucose-galactose malabsorption or primary renal glucosuria - Has history of, or currently active, illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com |
| Location Countries | United States, Argentina, Brazil, Czech Republic, Hungary, Korea, Republic of, Mexico, Romania, Russian Federation, Slovakia, South Africa, Turkey, Ukraine |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01809327 |
|---|---|
| Other Study ID Numbers | CR100034 |
| 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 | April 2014 |
Locations[ + expand ][ + ]
| United States, Alabama | Anniston, Alabama, United States Withdrawn |
|---|---|
| United States, Alabama | Birmingham, Alabama, United States Recruiting |
| United States, Arizona | Mesa, Arizona, United States Withdrawn |
| United States, Arizona | Phoenix, Arizona, United States Recruiting |
| United States, Arizona | Phoenix, Arizona, United States Completed |
| United States, California | Concord, California, United States Withdrawn |
| United States, California | Encinitas, California, United States Recruiting |
| United States, California | Greenbrae, California, United States Withdrawn |
| United States, California | Newport Beach, California, United States Completed |
| United States, California | Northridge, California, United States Recruiting |
| United States, California | Norwalk, California, United States Recruiting |
| United States, California | Rancho Cucamonga, California, United States Recruiting |
| United States, California | Spring Valley, California, United States Withdrawn |
| United States, California | Walnut Creek, California, United States Recruiting |
| United States, Colorado | Denver, Colorado, United States Recruiting |
| United States, Colorado | Northglenn, Colorado, United States Completed |
| United States, Connecticut | Waterbury, Connecticut, United States Withdrawn |
| United States, Florida | Bradenton, Florida, United States Withdrawn |
| United States, Florida | Brooksville, Florida, United States Withdrawn |
| United States, Florida | Hialeah, Florida, United States Recruiting |
| United States, Florida | Hialeah, Florida, United States Completed |
| United States, Florida | Hialeah, Florida, United States Withdrawn |
| United States, Florida | Miami, Florida, United States Withdrawn |
| United States, Florida | Miami, Florida, United States Recruiting |
| United States, Florida | New Port Richey, Florida, United States Recruiting |
| United States, Florida | Opa Locka, Florida, United States Recruiting |
| United States, Florida | Palm Harbor, Florida, United States Withdrawn |
| United States, Florida | St. Petersburg, Florida, United States Withdrawn |
| United States, Georgia | Perry, Georgia, United States Recruiting |
| United States, Idaho | Eagle, Idaho, United States Withdrawn |
| United States, Illinois | Springfield, Illinois, United States Withdrawn |
| United States, Indiana | Evansville, Indiana, United States Recruiting |
| United States, Louisiana | Baton Rouge, Louisiana, United States Withdrawn |
| United States, Louisiana | Mandeville, Louisiana, United States Recruiting |
| United States, Louisiana | Metairie, Louisiana, United States Recruiting |
| United States, Louisiana | Sunset, Louisiana, United States Recruiting |
| United States, Maine | Auburn, Maine, United States Withdrawn |
| United States, Maine | Portland, Maine, United States Withdrawn |
| United States, Maryland | Elkridge, Maryland, United States Withdrawn |
| United States, Massachusetts | Brockton, Massachusetts, United States Withdrawn |
| United States, Michigan | Bingham Farms, Michigan, United States Withdrawn |
| United States, Michigan | Flint, Michigan, United States Recruiting |
| United States, Michigan | Kalamazoo, Michigan, United States Completed |
| United States, Michigan | Royal Oak, Michigan, United States Recruiting |
| United States, Michigan | Troy, Michigan, United States Recruiting |
| United States, Mississippi | Olive Branch, Mississippi, United States Recruiting |
| United States, Mississippi | Picayune, Mississippi, United States Recruiting |
| United States, New Mexico | Albuquerque, New Mexico, United States Recruiting |
| United States, New Mexico | Albuquerque, New Mexico, United States Withdrawn |
| United States, New York | West Seneca, New York, United States Recruiting |
| United States, North Carolina | Hickory, North Carolina, United States Recruiting |
| United States, North Carolina | Mooresville, North Carolina, United States Recruiting |
| United States, Ohio | Cincinnati, Ohio, United States Withdrawn |
| United States, Ohio | Cleveland, Ohio, United States Withdrawn |
| United States, Ohio | Columbus, Ohio, United States Withdrawn |
| United States, Ohio | Franklin, Ohio, United States Recruiting |
| United States, Ohio | Mason, Ohio, United States Recruiting |
| United States, Ohio | Perrysburg, Ohio, United States Recruiting |
| United States, Ohio | Zanesville, Ohio, United States Recruiting |
| United States, Oklahoma | Oklahoma City, Oklahoma, United States Recruiting |
| United States, Oklahoma | Yukon, Oklahoma, United States Recruiting |
| United States, Oregon | Tualatin, Oregon, United States Recruiting |
| United States, Pennsylvania | Fleetwood, Pennsylvania, United States Recruiting |
| United States, Pennsylvania | Jersey Shore, Pennsylvania, United States Withdrawn |
| United States, Pennsylvania | Norristown, Pennsylvania, United States Recruiting |
| United States, Pennsylvania | Pittsburgh, Pennsylvania, United States Recruiting |
| United States, South Dakota | Rapid City, South Dakota, United States Recruiting |
| United States, Tennessee | Nashville, Tennessee, United States Recruiting |
| United States, Texas | Austin, Texas, United States Recruiting |
| United States, Texas | Bellaire, Texas, United States Recruiting |
| United States, Texas | Dallas, Texas, United States Recruiting |
| United States, Texas | Houston, Texas, United States Recruiting |
| United States, Texas | Houston, Texas, United States Withdrawn |
| United States, Texas | Pearland, Texas, United States Recruiting |
| United States, Texas | Plano, Texas, United States Recruiting |
| United States, Utah | Bountiful, Utah, United States Recruiting |
| United States, Utah | Salt Lake City, Utah, United States Withdrawn |
| United States, Utah | Salt Lake City, Utah, United States Recruiting |
| United States, Virginia | Danville, Virginia, United States Recruiting |
| United States, Virginia | Norfolk, Virginia, United States Recruiting |
| United States, Virginia | Richmond, Virginia, United States Recruiting |
| United States, Virginia | Virginia Beach, Virginia, United States Withdrawn |
| Argentina, MS | Olive Branch, MS, Argentina Withdrawn |
| Argentina | Buenos Aires, Argentina Recruiting |
| Argentina | Caba, Argentina Recruiting |
| Argentina | Cordoba, Argentina Recruiting |
| Argentina | Cordoba, Argentina Withdrawn |
| Argentina | Mar Del Plata, Argentina Recruiting |
| Argentina | Mendoza, Argentina Withdrawn |
| Argentina | Moron, Argentina Recruiting |
| Argentina | Rosario, Argentina Recruiting |
| Argentina | Rosario, Argentina Withdrawn |
| Argentina | Zarate, Argentina Recruiting |
| Brazil | Belem, Brazil Withdrawn |
| Brazil | Belo Horizonte, Brazil Withdrawn |
| Brazil | Brasilia, Brazil Withdrawn |
| Brazil | Campinas, Brazil Withdrawn |
| Brazil | Curitiba, Brazil Withdrawn |
| Brazil | Fortaleza, Brazil Withdrawn |
| Brazil | Goiânia, Brazil Withdrawn |
| Brazil | Marília, Brazil Withdrawn |
| Brazil | Mogi Das Cruzes, Brazil Withdrawn |
| Brazil | Passo Fundo, Brazil Recruiting |
| Brazil | Recife, Brazil Withdrawn |
| Brazil | Rio De Janeiro, Brazil Withdrawn |
| Brazil | Sao Paulo, Brazil Withdrawn |
| Brazil | Sao Paulo, Brazil Recruiting |
| Brazil | São Paulo, Brazil Recruiting |
| Brazil | São Paulo, Brazil Withdrawn |
| Czech Republic | Holesov, Czech Republic Withdrawn |
| Czech Republic | Kromeriz, Czech Republic Recruiting |
| Czech Republic | Pardubce, Czech Republic Withdrawn |
| Czech Republic | Pardubice, Czech Republic Recruiting |
| Czech Republic | Praha, Czech Republic Recruiting |
| Czech Republic | Praha 8, Czech Republic Recruiting |
| Czech Republic | Unicov, Czech Republic Recruiting |
| Hungary | Balatonfured, Hungary Recruiting |
| Hungary | Budapest, Hungary Recruiting |
| Hungary | Eger, Hungary Recruiting |
| Hungary | Gyõr, Hungary Recruiting |
| Hungary | Szentes, Hungary Withdrawn |
| Hungary | Szikszó, Hungary Recruiting |
| Hungary | Zalaegerszeg, Hungary Recruiting |
| Korea, Republic of | Goyang-Si, Korea, Republic of Recruiting |
| Korea, Republic of | Seoul, Korea, Republic of Recruiting |
| Korea, Republic of | Suwon, Korea, Republic of Recruiting |
| Mexico | Aguascalientes, Mexico Completed |
| Mexico | Celaya, Mexico Recruiting |
| Mexico | Culiacan, Mexico Withdrawn |
| Mexico | Durango, Mexico Recruiting |
| Mexico | Guadalajara, Mexico Recruiting |
| Mexico | Mexico, Mexico Recruiting |
| Mexico | Monterrey, Mexico Withdrawn |
| Mexico | Monterrey, Mexico Recruiting |
| Mexico | Monterrey, Mexico Not yet recruiting |
| Mexico | Pachuca De Soto, Mexico Recruiting |
| Mexico | Queretaro, Mexico Withdrawn |
| Mexico | Tampico, Mexico Recruiting |
| Puerto Rico | Carolina, Puerto Rico Recruiting |
| Puerto Rico | Ponce, Puerto Rico Recruiting |
| Puerto Rico | Ponce, Puerto Rico Withdrawn |
| Puerto Rico | San Juan, Puerto Rico Withdrawn |
| Puerto Rico | San Juan, Puerto Rico Recruiting |
| Puerto Rico | Trujillo Alto, Puerto Rico Recruiting |
| Romania | Bacau, Romania Recruiting |
| Romania | Brasov, Romania Recruiting |
| Romania | Bucharest, Romania Recruiting |
| Romania | Bucuresti, Romania Recruiting |
| Romania | Oradea, Romania Recruiting |
| Romania | Tg Mures, Romania Recruiting |
| Russian Federation | Arkhangelsk, Russian Federation Recruiting |
| Russian Federation | Arkhangelsk, Russian Federation Withdrawn |
| Russian Federation | Barnaul, Russian Federation Recruiting |
| Russian Federation | Barnaul, Russian Federation Withdrawn |
| Russian Federation | Chelyabinsk, Russian Federation Recruiting |
| Russian Federation | Kemerovo, Russian Federation Recruiting |
| Russian Federation | Kursk, Russian Federation Withdrawn |
| Russian Federation | Moscow, Russian Federation Withdrawn |
| Russian Federation | Moscow, Russian Federation Recruiting |
| Russian Federation | Novosibirsk, Russian Federation Withdrawn |
| Russian Federation | Omsk, Russian Federation Withdrawn |
| Russian Federation | Penza, Russian Federation Recruiting |
| Russian Federation | Perm, Russian Federation Withdrawn |
| Russian Federation | Rostov-On-Don, Russian Federation Recruiting |
| Russian Federation | Saint Petersburg, Russian Federation Withdrawn |
| Russian Federation | Saint Petersburg, Russian Federation Recruiting |
| Russian Federation | Saint-Petersburg, Russian Federation Recruiting |
| Russian Federation | Samara, Russian Federation Recruiting |
| Russian Federation | Saratov, Russian Federation Recruiting |
| Russian Federation | Smolensk, Russian Federation Recruiting |
| Russian Federation | St Petersburg, Russian Federation Not yet recruiting |
| Russian Federation | St Petersburg, Russian Federation Recruiting |
| Russian Federation | St-Petersburg, Russian Federation Recruiting |
| Russian Federation | Syktyvkar, Russian Federation Recruiting |
| Russian Federation | Tomsk, Russian Federation Recruiting |
| Russian Federation | Tyumen, Russian Federation Recruiting |
| Russian Federation | Voronezh, Russian Federation Recruiting |
| Slovakia | Banska Bystrica, Slovakia Recruiting |
| Slovakia | Bratislava, Slovakia Recruiting |
| Slovakia | Malacky, Slovakia Recruiting |
| Slovakia | Presov, Slovakia Recruiting |
| Slovakia | Rimavska Sobota, Slovakia Recruiting |
| Slovakia | Sahy, Slovakia Recruiting |
| Slovakia | Trebisov, Slovakia Recruiting |
| South Africa | Cape Town, South Africa Recruiting |
| South Africa | Durban, South Africa Recruiting |
| South Africa | Durban, South Africa Completed |
| South Africa | Halfway, South Africa Recruiting |
| South Africa | Johannesburg, South Africa Recruiting |
| South Africa | Johannesburg N/A, South Africa Recruiting |
| South Africa | Paarl, South Africa Withdrawn |
| South Africa | Soweto, Johannesburg, South Africa Recruiting |
| South Africa | Worcester, South Africa Withdrawn |
| South Africa | Worcester, South Africa Recruiting |
| Turkey | Ankara, Turkey Not yet recruiting |
| Turkey | Antalya, Turkey Not yet recruiting |
| Turkey | Canakkale, Turkey Not yet recruiting |
| Turkey | Denizli, Turkey Not yet recruiting |
| Turkey | Gaziantep, Turkey Not yet recruiting |
| Turkey | Isparta, Turkey Not yet recruiting |
| Turkey | Kahramanmaras, Turkey Not yet recruiting |
| Turkey | Kayseri, Turkey Not yet recruiting |
| Turkey | Malatya, Turkey Not yet recruiting |
| Turkey | Samsun, Turkey Not yet recruiting |
| Ukraine | Cherkasy, Ukraine Recruiting |
| Ukraine | Dnepropetrovsk, Ukraine Recruiting |
| Ukraine | Donetsk, Ukraine Recruiting |
| Ukraine | Ivano Frankivsk, Ukraine Recruiting |
| Ukraine | Kharkov, Ukraine Recruiting |
| Ukraine | Kiev, Ukraine Recruiting |
| Ukraine | Kyiv, Ukraine Recruiting |
| Ukraine | Lviv, Ukraine Recruiting |
| Ukraine | Odesa, Ukraine Recruiting |
| Ukraine | Poltava, Ukraine Recruiting |
| Ukraine | Simferopol, Ukraine Not yet recruiting |
| Ukraine | Sumy, Ukraine Recruiting |
| Ukraine | Vinnitsa, Ukraine Withdrawn |
| Ukraine | Zaporozhye, Ukraine Recruiting |