A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02139943
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Canagliflozin 100 mg — DRUG
    Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.
  • Canagliflozin 300 mg — DRUG
    Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.
  • Placebo — DRUG
    Matching placebo capsule will be taken orally, before the first meal of the day.

Study Details

The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).

Key Dates

Start date
May 31, 2014
Status verified
Jun 2016
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: Canagliflozin 100 mg
    Each participant will receive 100 mg of canagliflozin once daily for 18 weeks.
  • Experimental: Canagliflozin 300 mg
    Each participant will receive 300 mg of canagliflozin once daily for 18 weeks.
  • Placebo Comparator: Placebo
    Each participant will receive matching placebo once daily for 18 weeks

Primary Outcome Measure

Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight [ Time Frame: Week 18 ]

Locations (46)

FacilityCityStateZIPSite coordinators
-Little RockArkansas--
-ConcordCalifornia--
-La JollaCalifornia--
-Los AngelesCalifornia--
-Los GatosCalifornia--
-NorthridgeCalifornia--
-OrangeCalifornia--
-San FranciscoCalifornia--
-TemeculaCalifornia--
-TustinCalifornia--
-VenturaCalifornia--
-Walnut CreekCalifornia--
-DenverColorado--
-MiamiFlorida--
-Palm HarborFlorida--
-AtlantaGeorgia--
-HonoluluHawaii--
-Council BluffsIowa--
-Des MoinesIowa--
-Baton RougeLouisiana--
-RockvilleMaryland--
-BillingsMontana--
-OmahaNebraska--
-El PasoNevada--
-Las VegasNevada--
-NashuaNew Hampshire--
-BillingsNew York--
-SmithtownNew York--
-Morehead CityNorth Carolina--
-ColumbusOhio--
-MentorOhio--
-PhiladelphiaPennsylvania--
-GreerSouth Carolina--
-BloomingtonTennessee--
-ArlingtonTexas--
-AustinTexas--
-DallasTexas--
-El PasoTexas--
-HoustonTexas--
-San AntonioTexas--
-SchertzTexas--
-TomballTexas--
-OgdenUtah--
-Salt Lake CityUtah--
-SpokaneWashington--
-MilwaukeeWisconsin--

Find similar trials in Little Rock, AR

By condition
Type 1 diabetes
By specialty
Endocrinology

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