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The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

NCT01081834 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 678

Last updated 2017-02-23

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.

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 (Main Study) or 26 weeks (High Glycemic Substudy)

DRUG

Placebo

One matching placebo capsule orally once daily for 26 weeks (Main Study)

DRUG

Sitagliptin

One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC 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
2010-03-31
Primary Completion
2011-08-31
Completion
2012-03-31

Countries

  • United States
  • Austria
  • Colombia
  • Estonia
  • Guatemala
  • Iceland
  • India
  • Lithuania
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • South Africa
  • South Korea
  • Spain
  • Sweden

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 NCT01081834 on ClinicalTrials.gov