An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01340664
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin 50 mg — DRUG
    One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks
  • Placebo — DRUG
    1 placebo capsule taken orally twice daily with a meal for 18 weeks
  • Canagliflozin 150 mg — DRUG
    1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks
  • Metformin — DRUG
    The patient's stable daily dose of Metformin background therapy should be continued throughout the study.

Study Details

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Key Dates

Start date
Jul 31, 2011
Status verified
Sep 2014
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012

Study Design

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

Arms

  • Experimental: Canagliflozin 50 mg bid
    Each patient will receive 50 mg canagliflozin twice daily for 18 weeks.
  • Experimental: Canagliflozin 150 mg bid
    Each patient will receive 150 mg canagliflozin twice daily for 18 weeks
  • Placebo Comparator: Placebo
    Each patient will receive matching placebo twice daily for 18 weeks

Primary Outcome Measure

Change in HbA1c From Baseline to Week 18 [ Time Frame: Day 1 (Baseline) and Week 18 ]

Locations (26)

FacilityCityStateZIPSite coordinators
-Little RockArkansas--
-National CityCalifornia--
-Spring ValleyCalifornia--
-BradentonFlorida--
-MariannaFlorida--
-SavannahGeorgia--
-AvonIndiana--
-ValparaisoIndiana--
-MadisonvilleKentucky--
-MetairieLouisiana--
-CharlotteNorth Carolina--
-ColumbusOhio--
-MasonOhio--
-PerrysburgOhio--
-TulsaOklahoma--
-YukonOklahoma--
-Oregon CityOregon--
-PittsburghPennsylvania--
-East ProvidenceRhode Island--
-NashvilleTennessee--
-HoustonTexas--
-PearlandTexas--
-San AntonioTexas--
-BountifulUtah--
-Virginia BeachVirginia--
-MilwaukeeWisconsin--

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By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

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