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An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

NCT01340664 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2014-09-16

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 monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Canagliflozin 50 mg

One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks

DRUG

Placebo

1 placebo capsule taken orally twice daily with a meal for 18 weeks

DRUG

Canagliflozin 150 mg

1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks

DRUG

Metformin

The patient's stable daily dose of Metformin background therapy should be continued throughout the 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
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • Canada
  • Czechia
  • Mexico
  • Romania
  • Russia
  • Slovakia

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 NCT01340664 on ClinicalTrials.gov