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Clinical Trial Details

Trial ID: L5228
Source ID: NCT02139943
Associated Drug: Canagliflozin 100 Mg
Title: A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02139943/results
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Canagliflozin 100 mg|DRUG: Canagliflozin 300 mg|DRUG: Placebo
Outcome Measures: Primary: Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight, Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight., Week 18|Percentage of Participants With Adverse Events, Up to 22 Weeks |
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 352
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-05
Completion Date: 2015-06
Results First Posted: 2016-07-18
Last Update Posted: 2016-07-18
Locations: Little Rock, Arkansas, United States|Concord, California, United States|La Jolla, California, United States|Los Angeles, California, United States|Los Gatos, California, United States|Northridge, California, United States|Orange, California, United States|San Francisco, California, United States|Temecula, California, United States|Tustin, California, United States|Ventura, California, United States|Walnut Creek, California, United States|Denver, Colorado, United States|Miami, Florida, United States|Palm Harbor, Florida, United States|Atlanta, Georgia, United States|Honolulu, Hawaii, United States|Council Bluffs, Iowa, United States|Des Moines, Iowa, United States|Baton Rouge, Louisiana, United States|Rockville, Maryland, United States|Billings, Montana, United States|Omaha, Nebraska, United States|El Paso, Nevada, United States|Las Vegas, Nevada, United States|Nashua, New Hampshire, United States|Billings, New York, United States|Smithtown, New York, United States|Morehead City, North Carolina, United States|Columbus, Ohio, United States|Mentor, Ohio, United States|Philadelphia, Pennsylvania, United States|Greer, South Carolina, United States|Bloomington, Tennessee, United States|Arlington, Texas, United States|Austin, Texas, United States|Dallas, Texas, United States|El Paso, Texas, United States|Houston, Texas, United States|San Antonio, Texas, United States|Schertz, Texas, United States|Tomball, Texas, United States|Ogden, Utah, United States|Salt Lake City, Utah, United States|Spokane, Washington, United States|Milwaukee, Wisconsin, United States|Calgary, Alberta, Canada|London, Ontario, Canada|Oakville, Ontario, Canada|Thornhill, Ontario, Canada|Toronto, Ontario, Canada|Laval, Quebec, Canada|Sainte-Foy, Quebec, Canada
URL: https://clinicaltrials.gov/show/NCT02139943

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress