Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02243202
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    300 mg capsule, taken once daily, orally for 26 weeks.
  • Phentermine — DRUG
    15 mg capsule, taken once daily, orally for 26 weeks.
  • Matching Placebo to Canagliflozin — DRUG
    Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
  • Matching Placebo to Phentermine — DRUG
    Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.

Study Details

The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.

Key Dates

Start date
Sep 30, 2014
Status verified
Aug 2016
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: Canagliflozin + Phentermine
    300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
  • Experimental: Canagliflozin + Placebo (Phentermine)
    300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
  • Experimental: Phentermine + Placebo (Canagliflozin)
    15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
  • Placebo Comparator: Placebo
    Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.

Primary Outcome Measure

Percent Change From Baseline in Body Weight at Week 26 [ Time Frame: Week 26 ]

Locations (17)

FacilityCityStateZIPSite coordinators
-PhoenixArizona--
-Walnut CreekCalifornia--
-JacksonvilleFlorida--
-MeridianIdaho--
-EvansvilleIndiana--
-LexingtonKentucky--
-LouisvilleKentucky--
-New OrleansLouisiana--
-MilfordMassachusetts--
-ManliusNew York--
-WarwickRhode Island--
-Mt. PleasantSouth Carolina--
-NashvilleTennessee--
-DallasTexas--
-OdessaTexas--
-NorfolkVirginia--
-WauwatosaWisconsin--

Find similar trials in Phoenix, AZ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss

Related Studies