Canagliflozin-Mealtime Insulin Rescue

Part of paid clinical trials in Decatur, Georgia.

Sponsor
Foundation for Atlanta Veterans Education and Research, Inc.
Study ID
NCT02624908
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • canagliflozin — DRUG
    Subjects randomized to active drug will receive canagliflozin 100 mg . If study drug well tolerated, dose will be increased to 300 mg canagliflozin at Visit 4.
  • placebo — DRUG
    Subjects randomized to placebo will receive 100 mg placebo pill . If study drug well tolerated, dose will be increased to 300 mg placebo pill at Visit 4.

Study Details

24-week, randomized, double blind, placebo-controlled trial to evaluate safety and efficacy of canagliflozin as compared with placebo in reducing the need for mealtime insulin in subjects with type 2 diabetes currently using a basal-bolus insulin regimen.

Key Dates

Start date
Jan 31, 2016
Status verified
Aug 2022
Primary completion
Jul 31, 2018
Completion
Dec 31, 2022

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: canagliflozin
    Subjects randomized to this arm will start with 100 mg tablet and increase to 300 mg tablet at Visit 4 if well tolerated.
  • Placebo Comparator: placebo
    Subjects randomized to this arm will start with 100 mg tablet and increase to 300 mg tablet at Visit 4 if well tolerated.

Primary Outcome Measure

Number of patients who discontinue all pre-meal medications for at least one meal per day [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical CenterDecaturGeorgia30033-

Find similar trials in Decatur, GA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Atlanta VA Medical Center· Decatur, GA

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