An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

August 2, 2013 updated by: Janssen Research & Development, LLC

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

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 have reduced kidney function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (study drug assigned by chance), double blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of 2 different doses of canagliflozin (100 mg and 300 mg) compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with type 2 diabetes mellitus (T2DM) who have renal impairment (reduced kidney function) and who are not achieving an adequate response from current therapy to control their diabetes. Canagliflozin (also referred to as JNJ-28431754) is a drug that is being tested to see if it may be useful in treating patients diagnosed with T2DM. Approximately 240 patients will participate in the study for approximately 63 to 72 weeks, depending on the length of the pretreatment phase. The study will consist of a pretreatment phase, a 52 week double blind treatment phase, and a posttreatment phase. During the pretreatment phase, screening evaluations will be performed to see if patients meet the entry criteria for the study. In addition, routine clinical procedures will be performed (physical examination, vital signs measurements, and an electrocardiogram [ECG]), a blood and urine sample will be collected for routine clinical laboratory tests, and all antihyperglycemic therapy taken by patients will be reviewed. Patients who meet entrance criteria for the study and who currently take a stable antihyperglycemic agent (AHA) regimen according to the local prescribing information will be eligible for inclusion in the study. Patients who meet entrance criteria for the study but who are not taking a stable AHA regimen according to the local prescribing information will enter an AHA adjustment period that may last for up to 12 weeks. Patients will receive once daily treatment with study drug in addition to their current stable diabetes regimen (eg, diet, exercise, and medication therapy). Patients will continue to take their assigned treatment for 52 weeks (includes a 26-week core double-blind treatment period and a 26-week extension double-blind treatment period). During the study, if a patient's blood sugar remains high despite treatment with study drug in combination with their other antidiabetic agents, the study physician will modify the patient's treatment. If patients take insulin and experience low blood sugar (hypoglycemia), the dose of insulin may be modified. During the study, patients will be monitored for safety by review of adverse events, results from safety laboratory tests (including chemistry, hematology, and urinalysis), ECGs, vital signs measurements, body weight, physical examinations, self-monitored blood glucose, and collection of potential hypoglycemic episodes reported by patients on diary cards. The safety of patients in this study will also be monitored by a company internal Medical Safety Review Committee (MSRC). An Independent Data Monitoring Committee (IDMC) will evaluate cardiovascular (CV) events that are reported across the entire clinical development program for canagliflozin. Patients who complete the Week 52 visit or who discontinue treatment early and are withdrawn from the study will have end-of-study evaluations performed and a follow-up telephone interview conducted by study personnel approximately 30 days (but no more than 42 days) after the last dose of study drug to collect any serious adverse events that occurred since their last study visit. The primary outcome measures in the study are to assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c, a blood test used to measure the control of diabetes) after 26 weeks of treatment and to assess the safety and tolerability of canagliflozin from time of signed informed consent to study end (includes up to 30 days following the last dose of study drug). All patients will take a single-blind placebo capsule once daily for 2 weeks before randomization to double-blind study drug. After randomization, patients will take one capsule of canagliflozin (either 100 mg or 300 mg) or matching placebo orally (by mouth) with liquid once daily for 52 weeks before the first meal each day except on days when fasting or pharmacokinetic blood samples are collected in which case study drug will be taken after the visit immediately before the patient's next meal.

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 3

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
      • Camperdown, Australia
      • Gosford, Australia
      • Parkville, Australia
      • Reservoir, Australia
  • Belgium
      • Aalst, Belgium
      • Bonheiden, Belgium
      • Brussels, Belgium
      • Liège, Belgium
      • Sint-Niklaas, Belgium
      • Turnhout, Belgium
  • Brazil
      • Sao Paulo, Brazil
      • São Paulo, Brazil
  • Canada
      • Calgary, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Nova Scotia
      • Antigonish, Nova Scotia, Canada
      • Sydney, Nova Scotia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • London, Ontario, Canada
      • Smiths Falls, Ontario, Canada
      • Thornhill, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • Corbeil Essonnes, France
      • La Rochelle Cedex 1 Poitou-Cha, France
      • Le Creusot, France
      • Nantes N/A, France
      • Pierre Benite, France
      • Vandoeuvre Les Nancy, France
      • Venissieux, France
  • Germany
      • Dormagen, Germany
      • Dortmund, Germany
      • Dresden, Germany
      • Einbeck, Germany
      • Freiburg, Germany
      • Kassel, Germany
      • München, Germany
      • Schkeuditz, Germany
      • Würzburg, Germany
  • India
      • Aurangabad, India
      • Madurai, India
      • Pune, India
  • Korea, Republic of
      • Seognam-Si, Kyungki-Do, Korea, Republic of
      • Seoul, Korea, Republic of
  • Latvia
      • Daugavpils, Latvia
      • Ogre, Latvia
      • Riga, Latvia
  • Malaysia
      • Jalan Cheras N/A, Malaysia
      • Kajang, Malaysia
      • Kuala Lumpur N/A, Malaysia
      • Pulau Pinang, Malaysia
  • Mexico
      • Aguascalientes, Mexico
      • Culiacan, Mexico
      • Morelia, Mexico
      • Zapopan, Mexico
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Dunedin Nz, New Zealand
      • Nz, New Zealand
  • Poland
      • Lask, Poland
      • Lublin, Poland
      • Warszawa, Poland
  • Romania
      • Bucharest, Romania
      • Targoviste, Romania
  • Russian Federation
      • Chelyabinsk, Russian Federation
      • Kirov, Russian Federation
      • Kursk, Russian Federation
      • Moscow, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Petrozavodsk, Russian Federation
      • Rostov-On-Don, Russian Federation
      • Saint Petersburg, Russian Federation
      • St Petersburg, Russian Federation
      • Yaroslavl, Russian Federation
  • South Africa
      • Parow, Cape Town, South Africa
      • Pretoria, South Africa
      • Somerset West, South Africa
  • Spain
      • Barcelona, Spain
      • Ciudad Real, Spain
      • Madrid, Spain
      • Madrid N/A, Spain
      • San Sebastian De Los Reyes, Spain
      • Santa Cruz De Tenerife, Spain
      • Valencia, Spain
  • United States
    • California
      • Concord, California, United States
      • Fountain Valley, California, United States
      • San Diego, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Idaho
      • Nampa, Idaho, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Mississippi
      • Jackson, Mississippi, United States
      • Picayune, Mississippi, United States
    • Missouri
      • Chesterfield, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Ohio
      • Canal Fulton, Ohio, United States
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Zanesville, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Meridian, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • North Charleston, South Carolina, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Fairfax, Virginia, 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

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with T2DM not on an AHA or on any AHA in monotherapy or combination therapy (including oral or non oral agents)
  • Patients with reduced kidney function

Exclusion Criteria:

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
  • Kidney disease that required treatment with immunosuppressive therapy, history of dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria with hypoalbuminemia and/or edema), or inflammatory kidney disease
  • Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen
  • History of 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 52 weeks.
Drug: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information
EXPERIMENTAL: Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks.
Drug: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information
PLACEBO_COMPARATOR: Placebo
Each patient will receive matching placebo once daily for 52 weeks.
Drug: Placebo
One matching placebo capsule orally once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 26
Time Frame: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 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 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Time Frame: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 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 26
Percentage of Patients With HbA1c <7% at Week 26
Time Frame: Week 26
The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
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

June 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (ESTIMATE)

February 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 14, 2013

Last Update Submitted That Met QC Criteria

August 2, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017008
  • 28431754DIA3004 (OTHER: 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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