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

NCT00642278 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2013-07-19

Study results available
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Summary

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.

Conditions

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

Interventions

DRUG

Canagliflozin (JNJ-28431754)

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.

DRUG

Sitagliptin

One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.

DRUG

Placebo

One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Czechia
  • India
  • Malaysia
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642278 on ClinicalTrials.gov