CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

Part of paid clinical trials in Calera, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT00968812
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Glimepiride — DRUG
    Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.
  • Canagliflozin (JNJ-28431754) — DRUG
    Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.
  • Metformin — DRUG
    Metformin will be given orally at the protocol-specified dose for 104 weeks.

Study Details

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

Key Dates

Start date
Sep 30, 2009
Status verified
Dec 2016
Primary completion
Dec 31, 2011
Completion
Jan 31, 2013

Study Design

Enrollment
1,452 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Glimepiride
    Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
  • Experimental: Canagliflozin 100 mg
    Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
  • Experimental: Canagliflozin 300 mg
    Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.

Primary Outcome Measure

Change in HbA1c From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and Week 52 ]

Locations (43)

FacilityCityStateZIPSite coordinators
-CaleraAlabama--
-GilbertArizona--
-MesaArizona--
-TucsonArizona--
-JonesboroArkansas--
-Buena ParkCalifornia--
-EncinitasCalifornia--
-FresnoCalifornia--
-LincolnCalifornia--
-RosevilleCalifornia--
-San DiegoCalifornia--
-Westlake VillageCalifornia--
-ChipleyFlorida--
-MariannaFlorida--
-OldsmarFlorida--
-OrlandoFlorida--
-AugustaGeorgia--
-PerryGeorgia--
-NampaIdaho--
-ChicagoIllinois--
-Vernon HillsIllinois--
-ValparaisoIndiana--
-New OrleansLouisiana--
-ElkridgeMaryland--
-Bloomfield HillsMichigan--
-Las VegasNevada--
-Canal FultonOhio--
-GallipolisOhio--
-MasonOhio--
-PerrysburgOhio--
-TulsaOklahoma--
-YukonOklahoma--
-FleetwoodPennsylvania--
-GreenvilleSouth Carolina--
-NashvilleTennessee--
-HoustonTexas--
-OdessaTexas--
-PearlandTexas--
-San AntonioTexas--
-DanvilleVirginia--
-OlympiaWashington--
-MilwaukeeWisconsin--
-WauwatosaWisconsin--

Find similar trials in Calera, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

Related Studies