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The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

NCT01106625 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 469

Last updated 2013-06-20

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Canagliflozin

One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

DRUG

Placebo

One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

DRUG

Metformin

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

DRUG

Sulphonylruea

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-09-30
Completion
2012-04-30

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Guatemala
  • Hungary
  • Israel
  • Mexico
  • Puerto Rico
  • Russia
  • Spain
  • 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 NCT01106625 on ClinicalTrials.gov