NCT01128985

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

First QC Date

May 20, 2010

Last Update Submit

May 27, 2013

Conditions

Diabetes Mellitus, Type 2

Keywords

CanagliflozinPlaceboType 2 diabetes mellitusPharmacokineticPharmacodynamic

Outcome Measures

Primary Outcomes (1)

  • The concentration of canagliflozin and major metabolites (M5 and M7) in blood will be measured by protocol-specified pharmacokinetic parameters.

    At protocol-specified time points through Day 7

Secondary Outcomes (2)

  • The relationship between the concentration of glucose in patient blood measured by protocol-specified pharmacodynamic parameters

    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.

    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)

Study Arms (4)

001

EXPERIMENTAL

Canagliflozin 50 mg 50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7

Drug: Canagliflozin 50 mg

002

EXPERIMENTAL

Canagliflozin 100 mg 100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7

Drug: Canagliflozin 100 mg

003

EXPERIMENTAL

Canagliflozin 300 mg 300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.

Drug: Canagliflozin 300 mg

004

PLACEBO COMPARATOR

Placebo matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7

Drug: Placebo

Interventions

Canagliflozin 50 mgDRUG

50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7

001
Canagliflozin 100 mgDRUG

100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7

002
Canagliflozin 300 mgDRUG

300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.

003
PlaceboDRUG

matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7

004

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Fort Myers, Florida, United States

Location

Unknown Facility

Miramar, Florida, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 24, 2010

Study Start

March 1, 2010

Study Completion

July 1, 2010

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

US(2)