A study to assess the release profiles from fixed combination tablets (gliclazide MR/metformin)

ISRCTN	ISRCTN41840459
DOI	https://doi.org/10.1186/ISRCTN41840459
Protocol serial number	PKH-05720-001
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 31/08/2010
Registration date: 17/09/2010
Last edited: 09/05/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Peter Hodsman
Scientific

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

Study information

Primary study design	Interventional
Study design	Open-label, modified randomised four-way crossover study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A study to assess the release profiles from fixed combination tablets (gliclazide MR/metformin)
Study objectives	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(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	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 I
Drug / device / biological / vaccine name(s)	Gliclazide MR, metformin
Primary outcome measure(s)	Determination of the plasma gliclazide and metformin concentration-time data
Key secondary outcome measure(s)	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)
Completion date	30/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	12
Key inclusion criteria	1. Healthy male volunteers between the ages of 18 - 40 years inclusive 2. Normal clinical examination
Key exclusion criteria	Clinically significant abnormality in laboratory screening, including haematology, blood biochemistry and urinalysis
Date of first enrolment	13/09/2010
Date of final enrolment	30/11/2010

Locations

Countries of recruitment

Australia

Study participating centre

Nucleus Network

Melbourne
VIC 3004
Australia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/05/2023: The trial phase has been changed from 'Phase IV' to 'Phase I'.
18/04/2018: Internal review.
28/03/2018: Publication plan and IPD sharing statement were updated.
25/01/2018: Publication plan and IPD sharing statement added.
19/12/2017: results summary added.