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Clinical Trial Details

Trial ID: L3518
Source ID: NCT02912455
Associated Drug: Canagliflozin
Title: CARAT: Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02912455/results
Conditions: Diabetes Mellitus, Type 2|Obesity
Interventions: DRUG: canagliflozin|DRUG: Placebo (for canagliflozin)
Outcome Measures: Primary: Change at Six Months Versus Baseline in Hemoglobin A1c Value (%), The change in hemoglobin A1c from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery, 6 months | Secondary: Change in Fasting Glucose From Randomization, The change in fasting glucose from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery., 6 months|Change in Body Weight at Six Months Compared to Baseline, The change in body weight from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery., 6 months|Change in Total Cholesterol, The change in total cholesterol from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery, 6 months|Change in Diastolic Blood Pressure at Six Months Compared to Baseline, The change in diastolic blood pressure from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery, 6 months|Change in Adiponectin Levels at 6 Months Compared to Randomization, The change in adiponectin levels from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery., 6 months|Change in Leptin Levels at 6 Months Compared to Baseline, Change in leptin levels at 6 months compared to baseline The change in leptin levels from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery., 6 months|Change in CRP Levels at 6 Months Compared to Baseline, The change in C-reactive protein levels from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery., 6 months|Number of Participants Who Reported Hypoglycemia From Each Group (at a Frequency of 1 Episode), The number of participants who reported symptomatic hypoglycemia episodes from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery., 6 months|Change in Percent Body Fat as Measured by DEXA Scan at 6 Months Compared to Randomization, The change in body fat from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery., 6 months|Change in Systolic Blood Pressure at 6 Months Compared to Baseline, The Change in Systolic Blood Pressure From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery, 6 months|Change in Percentage of Lean Mass, Change in percentage of lean body mass as measured by DEXA scan at 6 months compared to randomization, 6 months|Change in Percentage of Truncal Fat, Change in percentage of truncal fat as measured by DEXA scan at 6 months compared to randomization, 6 months|Change in Percentage of Android Fat, Change in percentage of android fat as measured by DEXA scan at 6 months compared to randomization, 6 months|Change in Percentage of Gynoid Fat, Change in percentage of gynoid fat as measured by DEXA scan at 6 months compared to randomization, 6 months|Change in Spine Bone Mineral Density, Change in spine bone marrow density as measured by DEXA scan at 6 months compared to randomization, 6 months|Change in Leg Bone Mineral Density, Change in leg bone marrow density as measured by DEXA scan at 6 months compared to randomization, 6 months
Sponsor/Collaborators: Sponsor: The Cleveland Clinic | Collaborators: Janssen Scientific Affairs, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-01-05
Completion Date: 2018-07-19
Results First Posted: 2020-06-30
Last Update Posted: 2020-11-20
Locations: Cleveland Clinic, Cleveland, Ohio, 44195, United States
URL: https://clinicaltrials.gov/show/NCT02912455