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

September 5, 2014 updated by: Janssen Research & Development, LLC

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (T2DM) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should remain the same throughout the study.

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Phase 2

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

  • Canada
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Brampton, Ontario, Canada
      • Toronto, Ontario, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Czech Republic
      • Beroun, Czech Republic
      • Olomouc 9, Czech Republic
      • Ostrava, Czech Republic
      • Pardubice, Czech Republic
      • Pisek, Czech Republic
      • Prague 10, Czech Republic
      • Praha 11, Czech Republic
      • Znojmo, Czech Republic
  • Mexico
      • Aguascalientes, Mexico
      • Guadalajara, Jalisco., Mexico
      • Monterrey, Mexico
      • Tampico, Mexico
  • Romania
      • Bacau, Romania
      • Brasov, Romania
      • Bucharest, Romania
      • Cluj-Napoca, Romania
      • Galati, Romania
      • Targu Mures, Romania
  • Russian Federation
      • Kursk, Russian Federation
      • Moscow, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Samara, Russian Federation
      • Saratov, Russian Federation
      • St Petersburg, Russian Federation
      • St-Petersburg, Russian Federation
      • Tyumen, Russian Federation
      • Voronezh, Russian Federation
  • Slovakia
      • Banska Bystrica, Slovakia
      • Bratislava, Slovakia
      • Kosice, Slovakia
      • Presov, Slovakia
      • Sahy, Slovakia
      • Trebisov, Slovakia
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • National City, California, United States
      • Spring Valley, California, United States
    • Florida
      • Bradenton, Florida, United States
      • Marianna, Florida, United States
    • Georgia
      • Savannah, Georgia, United States
    • Indiana
      • Avon, Indiana, United States
      • Valparaiso, Indiana, United States
    • Kentucky
      • Madisonville, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
      • Mason, Ohio, United States
      • Perrysburg, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
      • Yukon, Oklahoma, United States
    • Oregon
      • Oregon City, Oregon, United States
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States
    • Rhode Island
      • East Providence, Rhode Island, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Pearland, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Bountiful, Utah, United States
    • Virginia
      • Virginia Beach, Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, 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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients must have a diagnosis of T2DM and be currently treated with metformin
  • Patients in the study must have a HbA1c between >=7 and <=10.5%
  • Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

Exclusion Criteria:

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months 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 50 mg bid
Each patient will receive 50 mg canagliflozin twice daily for 18 weeks.
Drug: Canagliflozin 50 mg
One canagliflozin 50-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.
Experimental: Canagliflozin 150 mg bid
Each patient will receive 150 mg canagliflozin twice daily for 18 weeks
Drug: Metformin
The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Drug: Canagliflozin 150 mg
1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks
Placebo Comparator: Placebo
Each patient will receive matching placebo twice daily for 18 weeks
Drug: Metformin
The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Drug: Placebo
1 placebo capsule taken orally twice daily with a meal for 18 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 18
Time Frame: Day 1 (Baseline) and Week 18
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
Time Frame: Day 1 (Baseline) and Week 18
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 18
Percent Change in Body Weight From Baseline to Week 18
Time Frame: Day 1 (Baseline) and Week 18
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
Day 1 (Baseline) and Week 18
Percentage of Patients With HbA1c <7% at Week 18
Time Frame: Week 18
The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Week 18

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

July 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017914
  • 28431754DIA2003 (Other Identifier: Janssen Research & Development, LLC)
  • 2010-024256-28 (EudraCT Number)

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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