NCT01088594

Brief Summary

A single centre, open, randomized, placebo controlled, 3 period cross-over study to evaluate the effects of single oral doses of pioglitazone 45mg, rosiglitazone 8mg and placebo on urinary sodium excretion in 12 healthy male volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

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

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_1 type-2-diabetes-mellitus

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

Study Start

First participant enrolled

February 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
Last Updated

March 17, 2010

Status Verified

March 1, 2010

Enrollment Period

28 days

First QC Date

February 26, 2010

Last Update Submit

March 16, 2010

Conditions

Type 2 Diabetes Mellitus

Keywords

urinary sodium excretionPioglitazoneRosiglitazoneMethodological study

Outcome Measures

Primary Outcomes (2)

  • Time-course urinary sodium excretion calculated on the Day 1 of each study period

    0-6 hours

  • Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period

    0-6 hours

Secondary Outcomes (2)

  • Sodium clearance on Day 1 of each study period

    0-6 hours

  • Creatinine clearance calculated on Day 1 of each study period

    0-6 hours

Study Arms (3)

1

EXPERIMENTAL

pioglitazone 45 mg

Drug: pioglitazone/rosiglitazone/placeboDrug: rosiglitazone/pioglitazone/placeboDrug: placebo/pioglitazone/rosiglitazoneDrug: pioglitazone/placebo/rosiglitazoneDrug: rosiglitazone/placebo/pioglitazoneDrug: placebo/rosiglitazone/pioglitazone

2

EXPERIMENTAL

Rosiglitazone 8 mg

Drug: pioglitazone/rosiglitazone/placeboDrug: rosiglitazone/pioglitazone/placeboDrug: placebo/pioglitazone/rosiglitazoneDrug: pioglitazone/placebo/rosiglitazoneDrug: rosiglitazone/placebo/pioglitazoneDrug: placebo/rosiglitazone/pioglitazone

3

PLACEBO COMPARATOR

Placebo

Drug: pioglitazone/rosiglitazone/placeboDrug: rosiglitazone/pioglitazone/placeboDrug: placebo/pioglitazone/rosiglitazoneDrug: pioglitazone/placebo/rosiglitazoneDrug: rosiglitazone/placebo/pioglitazoneDrug: placebo/rosiglitazone/pioglitazone

Interventions

pioglitazone/rosiglitazone/placeboDRUG

single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo

123
rosiglitazone/pioglitazone/placeboDRUG

single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo

123
placebo/pioglitazone/rosiglitazoneDRUG

single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg

123
pioglitazone/placebo/rosiglitazoneDRUG

single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg

123
rosiglitazone/placebo/pioglitazoneDRUG

single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg

123
placebo/rosiglitazone/pioglitazoneDRUG

single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg

123

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S337.1.004 Site #

London, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

PioglitazoneRosiglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Claire Nee

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 17, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 17, 2010

Record last verified: 2010-03

Locations

GB(1)