A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus

May 27, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the pharmacokinetics (blood levels of the drug) and pharmacodynamics (effects of the drug on the body) of canagliflozin after oral administration to patients with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (patients will assigned to 1 of 4 study treatments by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), study to assess the pharmacokinetics (blood levels) and pharmacodynamics (effects of the drug on the body) of canagliflozin compared to a placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM. Approximately 36 patients with T2DM will receive once-daily treatment with canagliflozin (50 mg, 100 mg, or 300 mg doses) or placebo for 7 days. Patients will participate in the study for approximately 9 weeks. Blood and urine samples will be collected at specified times before and after each dose of study drug for pharmacokinetic and pharmacodynamic analyses. A blood sample will also be collected before the first dose of study drug for pharmacogenomic analysis (ie, genetic testing) for possible use in characterizing the safety and/or efficacy of study drug in relation to the patient pharmacogenic profile. During the study, the safety and tolerability of canagliflozin will be evaluated by monitoring adverse events and findings from laboratory evaluations, vital signs measurements, and ECG measurements. The primary outcome measure in the study is the concentration of canagliflozin and its major metabolites (M5 and M7) in the blood measured by protocol-specified pharmacokinetic parameters at protocol specified time points through Day 7. Study drug will be taken orally (by mouth) once daily before the first meal each day. On Day -1, patients will take 1 dose of placebo in single-blind fashion (patient blinded) to determine baseline assessments. After randomization, patients will take single doses of double-blind canagliflozin (50 mg, 100 mg, or 300 mg) or matching placebo once daily for 7 days (Day 1 through Day 7).

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

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

  • United States
    • Florida
      • Fort Myers, Florida, United States
      • Miramar, Florida, 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

23 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients must have a diagnosis of T2DM for at least 1 year, but not more than 12 years prior to Day -1 of the study and be medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and electrocardiogram (ECG) performed at Screening
  • Patients must be on generally stable approved anti-hypeglycemic agent (AHA) regimen (i.e., with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to the Screening Visit
  • Patients must have fasting plasma glucose (FPG) concentrations between 7.8 mM (140 mg/dL) and 15 mM (270 mg/dL) on Day -2

Exclusion Criteria:

  • History of clinically significant diabetic complications including retinopathy, nephropathy, or macro albuminuria, neuropathy, gastroparesis, or diabetic ketoacidosis
  • History of type 1 diabetes mellitus (T1DM)
  • History of repeated severe hypoglycemic episodes 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
Canagliflozin 50 mg 50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
Drug: Canagliflozin 50 mg
50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
Experimental: 002
Canagliflozin 100 mg 100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
Drug: Canagliflozin 100 mg
100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
Experimental: 003
Canagliflozin 300 mg 300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.
Drug: Canagliflozin 300 mg
300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.
Placebo Comparator: 004
Placebo matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7
Drug: Placebo
matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The concentration of canagliflozin and major metabolites (M5 and M7) in blood will be measured by protocol-specified pharmacokinetic parameters.
Time Frame: At protocol-specified time points through Day 7
At protocol-specified time points through Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
The relationship between the concentration of glucose in patient blood measured by protocol-specified pharmacodynamic parameters
Time Frame: At protocol-specified time points from baseline to Day 7
At protocol-specified time points from baseline to Day 7
The safety and tolerability of canagliflozin will be determined by monitoring adverse events and findings from laboratory evaluations, vital signs measurements, and ECG measurements reported.
Time Frame: At protocol-specified time points from the time of screening (Day -44 to Day -23) to end-of-study (7 to 10 days after Day 7 or at the time of early withdrawal from the study)
At protocol-specified time points from the time of screening (Day -44 to Day -23) to end-of-study (7 to 10 days after Day 7 or at the time of early withdrawal from the study)

Collaborators and Investigators

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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Helpful Links

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

March 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 27, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017200
  • 28431754DIA1023

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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