An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes

Conditions

• Diabetes Mellitus, Non Insulin Dependent
• Diabetes Mellitus, Type II

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Canagliflozin (JNJ-28431754) — DRUG
  One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.
• Sitagliptin — DRUG
  One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
• Placebo — DRUG
  One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.

Study Details

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.

Key Dates

Start date

Apr 30, 2008

Status verified

Jul 2013

Primary completion

Jan 31, 2009

Completion

Jan 31, 2009

Study Design

Enrollment

451 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Canagliflozin 50 mg daily
  Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
• Experimental: Canagliflozin 100 mg daily
  Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
• Experimental: Canagliflozin 200 mg daily
  Each patient will receive 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
• Experimental: Canagliflozin 300 mg daily
  Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo capsule once daily (in the evening).
• Experimental: Canagliflozin 300 mg twice daily
  Each patient will receive 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
• Active Comparator: Sitagliptin 100 mg daily
  Each patient will receive 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
• Placebo Comparator: Placebo
  Each patient will receive matching placebo twice daily for 12 weeks.

Primary Outcome Measure

Change in HbA1c From Baseline to Week 12 [ Time Frame: Day 1 (Baseline) and Week 12 ]

Locations (30)