CARAT: Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT02912455
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a prospective, randomized clinical trial for patients with recurrent type 2 diabetes post-gastric bypass surgery that will compare a 6 month course of canagliflozin monotherapy vs. placebo on clinical outcomes of type 2 diabetes.

Key Dates

Start date
Jan 5, 2017
Status verified
Oct 2020
Primary completion
Jul 19, 2018
Completion
Jul 19, 2018

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Study Drug (canagliflozin)
    Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).
  • Placebo Comparator: Placebo
    Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Primary Outcome Measure

Change at Six Months Versus Baseline in Hemoglobin A1c Value (%) [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Type 2 diabetesObesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Cleveland Clinic· Cleveland, OH

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