A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

PHASE3CompletedINTERVENTIONAL
Enrollment

1,186

Participants

Timeline

Start Date

June 4, 2013

Primary Completion Date

December 2, 2014

Study Completion Date

December 2, 2014

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Canagliflozin 100 mg

One 100 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 100 mg arm) or with the evening meal (for the Canagliflozin 100 mg + Metformin XR arm).

DRUG

Canagliflozin 300 mg

One 300 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 300 mg arm) or with the evening meal (for the Canagliflozin 300 mg + Metformin XR arm).

DRUG

Metformin XR

One 500 mg tablet (Day 1 up to week 1); two 500 mg tablets (Week 1 up to Week 3); three 500 mg tablets (Week 3 to Week 6); four 500 mg tablets (Week 6 to Week 9). Tablets will be administered with the evening meal.

Trial Locations (129)

Unknown

Birmingham

Phoenix

Encinitas

Newport Beach

Northridge

Norwalk

Rancho Cucamonga

Walnut Creek

Denver

Northglenn

Hialeah

Miami

New Port Richey

Opa-locka

Perry

Evansville

Mandeville

Metairie

Sunset

Flint

Kalamazoo

Royal Oak

Troy

Olive Branch

Picayune

Albuquerque

West Seneca

Hickory

Mooresville

Franklin

Mason

Perrysburg

Zanesville

Oklahoma City

Yukon

Tualatin

Fleetwood

Norristown

Pittsburgh

Rapid City

Nashville

Austin

Bellaire

Dallas

Houston

Pearland

Plano

Bountiful

Salt Lake City

Danville

Norfolk

Richmond

Buenos Aires

Ciudad Autonoma Buenos Aires

Córdoba

Mar del Plata

Morón

Rosario

Zárate

Passo Fundo

São Paulo

Kroměříž

Pardubice

Prague

Uničov

Balatonfüred

Budapest

Eger

Szikszó

Zalaegerszeg

Celaya

Durango

Guadalajara

México

Monterrey

Pachuca

Tampico

Carolina

Ponce

San Juan

Trujillo Alto

Bacau

Brasov

Bucharest

Oradea

Tg Mures

Arkhangelsk

Barnaul

Chelyabinsk

Kemerovo

Moscow

Penza

Rostov-on-Don

Saint Petersburg

Samara

Saratov

Smolensk

Syktyvkar

Tomsk

Tyumen

Voronezh

Banská Bystrica

Bratislava

Malacky

Prešov

Rimavská Sobota

Šahy

Trebišov

Cape Town

Durban

Halfway

Johannesburg

Soweto, Johannesburg

Worcester

Goyang-si

Seoul

Suwon

Cherkasy

Dnipro

Donetsk

Ivano-Frankivsk

Kharkiv

Kiev

Kyiv

Lviv

Odesa

Poltava

Sumy

Zaporizhzhya

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01809327 - A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise | Biotech Hunter | Biotech Hunter