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Clinical Trial Details

Trial ID: L2193
Source ID: NCT01809327
Associated Drug: Canagliflozin 100 Mg
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
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01809327/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Canagliflozin 100 mg|DRUG: Canagliflozin 300 mg|DRUG: Metformin XR
Outcome Measures: Primary: Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26, The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups., Day 1 (Baseline) and Week 26 | Secondary: Percent Change in Body Weight From Baseline to Week 26, The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups., Day 1 (Baseline) and Week 26|Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26, The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups., Week 26|Change in Systolic Blood Pressure From Baseline at Week 26, The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups., Day 1 (Baseline) and Week 26|Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26, The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups., Day 1 (Baseline) and Week 26|Percent Change in Triglycerides From Baseline to Week 26, The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups., Day 1 (Baseline) and Week 26|Number of Participants With Treatment Emergent Adverse Events (AEs), An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state., Up to 30 weeks of last study drug administration
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1186
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-06-04
Completion Date: 2014-12-02
Results First Posted: 2016-01-06
Last Update Posted: 2017-07-11
Locations: Birmingham, Alabama, United States|Phoenix, Arizona, United States|Encinitas, California, United States|Newport Beach, California, United States|Northridge, California, United States|Norwalk, California, United States|Rancho Cucamonga, California, United States|Walnut Creek, California, United States|Denver, Colorado, United States|Northglenn, Colorado, United States|Hialeah, Florida, United States|Miami, Florida, United States|New Port Richey, Florida, United States|Opa-locka, Florida, United States|Perry, Georgia, United States|Evansville, Indiana, United States|Mandeville, Louisiana, United States|Metairie, Louisiana, United States|Sunset, Louisiana, United States|Flint, Michigan, United States|Kalamazoo, Michigan, United States|Royal Oak, Michigan, United States|Troy, Michigan, United States|Olive Branch, Mississippi, United States|Picayune, Mississippi, United States|Albuquerque, New Mexico, United States|West Seneca, New York, United States|Hickory, North Carolina, United States|Mooresville, North Carolina, United States|Franklin, Ohio, United States|Mason, Ohio, United States|Perrysburg, Ohio, United States|Zanesville, Ohio, United States|Oklahoma City, Oklahoma, United States|Yukon, Oklahoma, United States|Tualatin, Oregon, United States|Fleetwood, Pennsylvania, United States|Norristown, Pennsylvania, United States|Pittsburgh, Pennsylvania, United States|Rapid City, South Dakota, United States|Nashville, Tennessee, United States|Austin, Texas, United States|Bellaire, Texas, United States|Dallas, Texas, United States|Houston, Texas, United States|Pearland, Texas, United States|Plano, Texas, United States|Bountiful, Utah, United States|Salt Lake City, Utah, United States|Danville, Virginia, United States|Norfolk, Virginia, United States|Richmond, Virginia, United States|Buenos Aires, Argentina|Ciudad Autonoma Buenos Aires, Argentina|Ciudad Autonoma De Buenos Aires, Argentina|Cordoba, Argentina|Mar Del Plata, Argentina|Moron, Argentina|Rosario, Argentina|Zarate, Argentina|Passo Fundo, Brazil|Sao Paulo, Brazil|São Paulo, Brazil|Kromeriz, Czechia|Pardubice, Czechia|Praha 8, Czechia|Praha, Czechia|Unicov, Czechia|Balatonfured, Hungary|Budapest, Hungary|Eger, Hungary|Szikszó, Hungary|Zalaegerszeg, Hungary|Goyang-Si, Korea, Republic of|Seoul, Korea, Republic of|Suwon, Korea, Republic of|Celaya, Mexico|Durango, Mexico|Guadalajara, Mexico|Mexico, Mexico|Monterrey, Mexico|Pachuca De Soto, Mexico|Tampico, Mexico|Carolina, Puerto Rico|Ponce, Puerto Rico|San Juan, Puerto Rico|Trujillo Alto, Puerto Rico|Bacau, Romania|Brasov, Romania|Bucharest, Romania|Bucuresti, Romania|Oradea, Romania|Tg Mures, Romania|Arkhangelsk, Russian Federation|Barnaul, Russian Federation|Chelyabinsk, Russian Federation|Kemerovo, Russian Federation|Moscow, Russian Federation|Penza, Russian Federation|Rostov-On-Don, Russian Federation|Saint Petersburg, Russian Federation|Saint-Petersburg, Russian Federation|Samara, Russian Federation|Saratov, Russian Federation|Smolensk, Russian Federation|St Petersburg, Russian Federation|St-Petersburg, Russian Federation|Syktyvkar, Russian Federation|Tomsk, Russian Federation|Tyumen, Russian Federation|Voronezh, Russian Federation|Banska Bystrica, Slovakia|Bratislava, Slovakia|Malacky, Slovakia|Presov, Slovakia|Rimavska Sobota, Slovakia|Sahy, Slovakia|Trebisov, Slovakia|Cape Town, South Africa|Durban, South Africa|Halfway, South Africa|Johannesburg N/A, South Africa|Johannesburg, South Africa|Soweto, Johannesburg, South Africa|Worcester, South Africa|Cherkasy, Ukraine|Dnepropetrovsk, Ukraine|Donetsk, Ukraine|Ivano Frankivsk, Ukraine|Kharkov, Ukraine|Kiev, Ukraine|Kyiv, Ukraine|Lviv, Ukraine|Odesa, Ukraine|Poltava, Ukraine|Sumy, Ukraine|Zaporozhye, Ukraine
URL: https://clinicaltrials.gov/show/NCT01809327

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress