A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea

PHASE3CompletedINTERVENTIONAL
Enrollment

678

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Placebo

Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).

DRUG

Canagliflozin 100mg

Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).

DRUG

Canagliflozin 300mg

Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).

DRUG

Metformin

The participant's stable dose of background therapy of metformin should be continued throughout the study.

DRUG

Sulphonylurea

The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.

Trial Locations (25)

Unknown

Baotou

Beijing

Changchun

Changsha

Chengdu

Chongqing

Guangzhou

Hangzhou

Harbin

Nanchang

Nanjing

Nanning

Shanghai

Shenyang

Shiyan

Siping

Suzhou

Tianjin

Wuxi

Xi'an

Kota Bharu

Kuala Selangor

Pulau Pinang

Hanoi

Ho Chi Minh City

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01381900 - A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea | Biotech Hunter | Biotech Hunter