NCT00963768

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie, blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of JNJ-28431754 compared to placebo in patients with Type 2 diabetes mellitus.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
116

participants targeted

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

Timeline
Completed

Started Jun 2007

Geographic Reach
3 countries

3 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

June 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2009

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

August 20, 2009

Last Update Submit

April 22, 2014

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2JNJ-28431754CanagliflozinSodium Glucose Co-transporter (SGLT2 inhibitor)PharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • The number of patients with adverse events as a measure of safety and tolerability

    Up to 34 days (baseline [Day -1] through follow up [10 days following Day 22 visit])

Secondary Outcomes (5)

  • Change from baseline (Day -1) for mean 24-hour plasma glucose concentration

    Day -1 through Day 16

  • Change from baseline 24-hour urinary glucose excretion (UGE)

    Day -1 through 16

  • Change from baseline mean fasting plasma glucose

    Day -1 through Day 16

  • Change from baseline mean morning fasting body weight

    Day -1 through 20

  • Renal glucose threshold

    Day -1 through Day 16

Study Arms (5)

Cohort 1

EXPERIMENTAL

JNJ-28431754 30 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Drug: JNJ 28431754Drug: Placebo

Cohort 2

EXPERIMENTAL

JNJ-28431754 100 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Drug: JNJ 28431754Drug: Placebo

Cohort 3

EXPERIMENTAL

JNJ-28431754 300 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Drug: JNJ 28431754Drug: Placebo

Cohort 4

EXPERIMENTAL

JNJ-28431754 600 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Drug: JNJ 28431754Drug: Placebo

Cohort 5

EXPERIMENTAL

JNJ-28431754 at 30 mg/day, 100 mg/day, or 300 mg/day or placebo (the dose level to be determined from the prior cohort of patients tested and considered to be well tolerated).

Drug: JNJ 28431754Drug: Placebo

Interventions

JNJ 28431754DRUG

A liquid suspension of 30 mg, 100 mg, 300 mg of JNJ-28431754 taken once (or twice) daily or 600 mg taken once daily will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser for 14 days (Day 1 and Days 3 through 16).

Also known as: Canagliflozin
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5
PlaceboDRUG

A liquid suspension of placebo will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser once or twice daily for 14 days (Day 1 and Days 3 through 16).

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

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

You may qualify if:

  • Patients must have been diagnosed with Type 2 Diabetes for at least one year before screening
  • Patients must be taking a stable dose of oral (by mouth) anti-diabetic monotherapy or a combination of two anti-diabetic medications
  • Males or postmenopausal or surgically sterile women (post-menopausal is defined as no menses for at least 18 months prior to study start or no menses for 6 to 18 months)
  • Body mass index (weight in kg/height in m2) should be between 20 to 39.9 kg/m2

You may not qualify if:

  • History of Type 1, brittle diabetes or secondary forms of diabetes
  • History of repeated severe hypoglycemic episodes
  • History of diabetic complications including retinopathy, nephropathy, neuropathy, gastroparesis, or ketoacidosis
  • History of, or currently active illness including but not limited to cardiovascular disease, hematological disease, respiratory disease, hepatic or gastrointestinal disease, endocrine/metabolic disorders, neurologic or psychiatric disease, or malignant neoplasms considered by the Investigator to be clinically significant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Chula Vista, California, United States

Location

Unknown Facility

Neuss, Germany

Location

Unknown Facility

Seoul, South Korea

Location

Related Publications (2)

  • Sha S, Devineni D, Ghosh A, Polidori D, Hompesch M, Arnolds S, Morrow L, Spitzer H, Demarest K, Rothenberg P. Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes. PLoS One. 2014 Sep 30;9(9):e110069. doi: 10.1371/journal.pone.0110069. eCollection 2014.

    PMID: 25268802DERIVED

  • Sha S, Devineni D, Ghosh A, Polidori D, Hompesch M, Arnolds S, Morrow L, Spitzer H, Demarest K, Rothenberg P. Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes. PLoS One. 2014 Aug 28;9(8):e105638. doi: 10.1371/journal.pone.0105638. eCollection 2014.

    PMID: 25166023DERIVED

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 24, 2009

Study Start

June 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 23, 2014

Record last verified: 2014-04

Locations

DE(1)KR(1)US(1)