Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/08/2010
Date assigned
17/09/2010
Last edited
14/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Hodsman

ORCID ID

Contact details

Nucleus Network
5th Floor Burnet Tower
AMREP
Precinct
89 Commercial road
Melbourne
VIC 3004
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PKH-05720-001

Study information

Scientific title

Acronym

Study hypothesis

To compare the release profiles from three fixed combination tablets (gliclazide MR 60 mg metformin) with the free combination and with a 60 mg gliclazide oral solution.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Open-label, modified randomised four-way crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes

Intervention

Five periods, single administration: one oral solution of 60 mg gliclazide, three different gliclazide MR 60 mg - metformin fixed tablet combinations and free combination (gliclazide MR 60 mg and metformin) tablets.

Intervention type

Drug

Phase

Phase IV

Drug names

Gliclazide MR, metformin

Primary outcome measures

Determination of the plasma gliclazide and metformin concentration-time data

Secondary outcome measures

1. Adverse events (at all visits)
2. Physical examination (at all visits)
3. 12-lead ECG (at ASSE visit and at the end-of-study visit)
4. Biochemistry and haematology (at ASSE visit, at D1 and at the end-of-study visit)

Overall trial start date

13/09/2010

Overall trial end date

30/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy male volunteers between the ages of 18 - 40 years inclusive
2. Normal clinical examination

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12 completed subjects as a minimum

Participant exclusion criteria

Clinically significant abnormality in laboratory screening, including haematology, blood biochemistry and urinalysis

Recruitment start date

13/09/2010

Recruitment end date

30/11/2010

Locations

Countries of recruitment

Australia

Trial participating centre

Nucleus Network
Melbourne
VIC 3004
Australia

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes