NCT01273558

Brief Summary

The purpose of this study is to compare the results from two methods used to determine the renal threshold for glucose excretion (defined as the lowest plasma glucose concentration at which appreciable amounts of glucose appear in the urine) in untreated patients with type 2 diabetes mellitus and in patients with type 2 diabetes mellitus who are treated with 100 mg once-daily canigliflozin for 8 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 10, 2010

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

First QC Date

December 10, 2010

Last Update Submit

April 19, 2013

Conditions

Diabetes Mellitus, Type 2

Keywords

CanagliflozinRenal threshold for glucosePharmacodynamics

Outcome Measures

Primary Outcomes (2)

  • RTG values using the MMTT and the stepwise hyperglycemic clamp methods

    On Days 1 and 2 (Part 1)

  • RTG values using the MMTT and the stepwise hyperglycemic clamp methods

    On Days 7 and 8 (Part 2)

Secondary Outcomes (4)

  • Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure

    On Days 1 and 2 (Part 1)

  • Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure

    On Days 7 and 8 (Part 2)

  • Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure

    On Days 1 and 2 (Part 1)

  • Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure

    On Days 7 and 8 (Part 2)

Study Arms (2)

Part 1: no Intervention

NO INTERVENTION

In Part 1 of the study, patients will not receive any study drug.

Part 2: canagliflozin

EXPERIMENTAL

In Part 2 of the study, patients will receive canagliflozin once daily on Days 1 through 8.

Drug: Canagliflozin

Interventions

CanagliflozinDRUG

One 100 mg capsule taken orally (by mouth) on Days Days 1-8

Part 2: canagliflozin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with T2DM who are not receiving treatment with any anti-hyperglycemic agents (AHAs) for at least 12 weeks, or who are receiving treatment with a stable dose and regimen of metformin monotherapy for at least 12 weeks and have a hemoglobin A1c (HbA1c) in the range of \>=7% to \<=10%

You may not qualify if:

  • History of Type 1, "brittle" diabetes or secondary forms of diabetes
  • History of 1 or more severe hypoglycemic episodes
  • History of diabetic complications considered to be clinically significant by the Investigator
  • History of or current illness considered to be clinically significant by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuss, Germany

Location

Related Publications (1)

  • Polidori D, Sha S, Ghosh A, Plum-Morschel L, Heise T, Rothenberg P. Validation of a novel method for determining the renal threshold for glucose excretion in untreated and canagliflozin-treated subjects with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 May;98(5):E867-71. doi: 10.1210/jc.2012-4205. Epub 2013 Apr 12.

    PMID: 23585665DERIVED

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
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2010

First Posted

January 10, 2011

Study Start

January 1, 2011

Study Completion

July 1, 2011

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations

DE(1)