Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2015-02-28
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than absorb, glucose. Canagliflozin is also often associated with weight loss.
The study population will generally be type 2 diabetics, ages 18-75 years old, who are overweight or obese.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of SGLT-2 Inhibition on Hepatic Glucose and Energy Metabolism
NCT02558270
Renal Mechanism of SGLT2 Inhibition
NCT05507892
SGLT2 Inhibition in Older Obese Adults With Pre-diabetes
NCT04401904
SGLT-2 Inhibitor Effects on Cardiac and Hepatic Metabolic Profiles for the Diabetes Patients Combined With Obesity
NCT05764811
Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?
NCT02520518
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Canagliflozin
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Canagliflozin
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Placebo
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Placebo
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Canagliflozin
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Placebo
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. BMI 25-45 kg/m2
3. Hemoglobin A1C \> 6.5% but \< 9%
4. Normal renal function (GFR \> 60)
5. Age 18-75
Exclusion Criteria
2. History of recurrent UTI or mycotic genital infections
3. Treatment with insulin or a GLP1 agent
4. Pregnant or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Scientific Affairs, LLC
INDUSTRY
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jody Dushay
Principle Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014P000335
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.