A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

October 28, 2016 updated by: Janssen Research & Development, LLC

A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy

The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin >=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Coffs Harbour, Australia
      • Freemantle, Australia
      • Geelong, Australia
      • Heidelberg, Australia
      • Herston, Australia
      • Melbourne, Australia
      • Merewether, Australia
      • Sherwood, Australia
      • Sydney, Australia
      • Wollongong, Australia
  • Canada
    • Ontario
      • Brampton, Ontario, Canada
      • Hawkesbury, Ontario, Canada
      • Toronto, Ontario, Canada
  • France
      • La Rochelle Cedex 1 Poitou-Cha, France
      • La Tronche, France
      • Nancy, France
      • Narbonne Cedex, France
      • Nice Cedex 3, France
      • Paris Cedex 15, France
      • Venissieux, France
  • Germany
      • Freiburg, Germany
      • Fulda, Germany
      • Hamburg, Germany
      • Münster, Germany
      • Neuwied, Germany
      • Pirna, Germany
      • Speyer, Germany
  • United States
    • Alabama
      • Montgomery, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Northridge, California, United States
      • Norwalk, California, United States
      • Rancho Cucamonga, California, United States
      • San Ramon, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Denver, Colorado, United States
      • Littleton, Colorado, United States
    • Florida
      • Cooper City, Florida, United States
      • Miami, Florida, United States
      • North Miami Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Perry, Georgia, United States
    • Kansas
      • Shawnee Mission, Kansas, United States
    • Louisiana
      • Marrero, Louisiana, United States
      • Metairie, Louisiana, United States
      • Metarie, Louisiana, United States
    • Maryland
      • Rockville, Maryland, United States
    • Mississippi
      • Jackson, Mississippi, United States
      • Picayune, Mississippi, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
    • Texas
      • Arlington, Texas, United States
      • San Antonio, Texas, United States
      • Sugarland, Texas, United States
    • Utah
      • Bountiful, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have a diagnosis of type 2 diabetes mellitus
  • Must have a screening HbA1c of >=7.5% to <=10.5%
  • Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening

Exclusion Criteria:

  • History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria
  • A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening
  • eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for women
  • Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)
  • Major surgery (ie, requiring general anesthesia) within 12 weeks before screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canagliflozin (JNJ-28431754)
Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily.
Drug: Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily.
Drug: Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily.
Placebo Comparator: Placebo
Each participant will receive placebo (inactive medication) once daily for 28 weeks.
Drug: Placebo
One placebo capsule taken orally (by mouth) once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Time Frame: Baseline and Week 26
Baseline and Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time Frame: Baseline and Week 26
Baseline and Week 26
Percent Change From Baseline in Body Weight at Week 26
Time Frame: Baseline and Week 26
Baseline and Week 26
Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26
Time Frame: Week 26
Week 26
Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Time Frame: Baseline and Week 26
Baseline and Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 30, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR103477
  • 2013-004819-40 (EudraCT Number)
  • 28431754DIA4004 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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