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The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

NCT01137812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2015-01-15

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin 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

Sitagliptin 100 mg

One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea

DRUG

Canagliflozin 300 mg

One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea

DRUG

Metformin

Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.

DRUG

Sulphonylurea

Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • India
  • Israel
  • Malaysia
  • Netherlands
  • New Zealand
  • Poland
  • Singapore
  • South Korea
  • Ukraine

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 NCT01137812 on ClinicalTrials.gov