A study to assess the release profiles from fixed combination tablets (gliclazide MR/metformin)
| ISRCTN | ISRCTN41840459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41840459 |
| Secondary identifying numbers | PKH-05720-001 |
- 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
Scientific
Nucleus Network
5th Floor Burnet Tower, AMREP
Precinct, 89 Commercial road
Melbourne
VIC 3004
Australia
Study information
| Study design | Open-label, modified randomised four-way crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Gliclazide MR, metformin |
| Primary outcome measure | 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 study start date | 13/09/2010 |
| Completion date | 30/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 completed subjects as a minimum |
| 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
VIC 3004
Australia
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Summary results are published in https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature. |
| 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 |
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.
