Type 2 Diabetes MellitusPhase 1NCT01088594
A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers
A Phase 1 study of Type 2 Diabetes Mellitus, run by Solvay Pharmaceuticals at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Inclusion Criteria Volunteers with Body Mass Index 18.0-28.0 kg/m2 Exclusion Criteria Clinically relevant medical history
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- pioglitazone/rosiglitazone/placebo, rosiglitazone/pioglitazone/placebo, placebo/pioglitazone/rosiglitazone, pioglitazone/placebo/rosiglitazone, rosiglitazone/placebo/pioglitazone
- Keywords
- urinary sodium excretion, Pioglitazone, Rosiglitazone, Methodological study
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazone/rosiglitazone/placeboDrug
single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo
rosiglitazone/pioglitazone/placeboDrug
single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo
placebo/pioglitazone/rosiglitazoneDrug
single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg
pioglitazone/placebo/rosiglitazoneDrug
single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg
rosiglitazone/placebo/pioglitazoneDrug
single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg
placebo/rosiglitazone/pioglitazoneDrug
single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | pioglitazone 45 mg Receives: Drug: pioglitazone/rosiglitazone/placebo; Drug: rosiglitazone/pioglitazone/placebo; Drug: placebo/pioglitazone/rosiglitazone; Drug: pioglitazone/placebo/rosiglitazone; Drug: rosiglitazone/placebo/pioglitazone; Drug: placebo/rosiglitazone/pioglitazone |
| 2 | Experimental | Rosiglitazone 8 mg Receives: Drug: pioglitazone/rosiglitazone/placebo; Drug: rosiglitazone/pioglitazone/placebo; Drug: placebo/pioglitazone/rosiglitazone; Drug: pioglitazone/placebo/rosiglitazone; Drug: rosiglitazone/placebo/pioglitazone; Drug: placebo/rosiglitazone/pioglitazone |
| 3 | Placebo comparator | Placebo Receives: Drug: pioglitazone/rosiglitazone/placebo; Drug: rosiglitazone/pioglitazone/placebo; Drug: placebo/pioglitazone/rosiglitazone; Drug: pioglitazone/placebo/rosiglitazone; Drug: rosiglitazone/placebo/pioglitazone; Drug: placebo/rosiglitazone/pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-course urinary sodium excretion calculated on the Day 1 of each study period
Measured: 0-6 hours
Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period
Measured: 0-6 hours
Secondary outcomes (2)
Sodium clearance on Day 1 of each study period
Measured: 0-6 hours
Creatinine clearance calculated on Day 1 of each study period
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claire Nee, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088594
- Sponsor's protocol ID
- S337.1.004
- Other IDs
- 2009-017263-42, 2009
- Status last verified
- Mar 2010
- First submitted
- 26 Feb 2010
- Last updated
- 17 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01088594
- Acronym / sponsor ID
- S337.1.004
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- urinary sodium excretion, Pioglitazone, Rosiglitazone, Methodological study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pioglitazone/rosiglitazone/placebo, Drug: rosiglitazone/pioglitazone/placebo, Drug: placebo/pioglitazone/rosiglitazone, Drug: pioglitazone/placebo/rosiglitazone, Drug: rosiglitazone/placebo/pioglitazone, Drug: placebo/rosiglitazone/pioglitazonepioglitazone 45 mg |
| 2 | Experimental | Drug: pioglitazone/rosiglitazone/placebo, Drug: rosiglitazone/pioglitazone/placebo, Drug: placebo/pioglitazone/rosiglitazone, Drug: pioglitazone/placebo/rosiglitazone, Drug: rosiglitazone/placebo/pioglitazone, Drug: placebo/rosiglitazone/pioglitazoneRosiglitazone 8 mg |
| 3 | Placebo comparator | Drug: pioglitazone/rosiglitazone/placebo, Drug: rosiglitazone/pioglitazone/placebo, Drug: placebo/pioglitazone/rosiglitazone, Drug: pioglitazone/placebo/rosiglitazone, Drug: rosiglitazone/placebo/pioglitazone, Drug: placebo/rosiglitazone/pioglitazonePlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pioglitazone/rosiglitazone/placebosingle oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo | Drug | 1, 2, 3 |
| rosiglitazone/pioglitazone/placebosingle oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo | Drug | 1, 2, 3 |
| placebo/pioglitazone/rosiglitazonesingle oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg | Drug | 1, 2, 3 |
| pioglitazone/placebo/rosiglitazonesingle oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg | Drug | 1, 2, 3 |
| rosiglitazone/placebo/pioglitazonesingle oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg | Drug | 1, 2, 3 |
| placebo/rosiglitazone/pioglitazonesingle oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg | Drug | 1, 2, 3 |
Primary outcome
Time-course urinary sodium excretion calculated on the Day 1 of each study period
Time frame: 0-6 hours
Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period
Time frame: 0-6 hours
2 secondary outcomes
Sodium clearance on Day 1 of each study period
Time frame: 0-6 hours
Creatinine clearance calculated on Day 1 of each study period
Time frame: 0-6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Nee study director
Solvay Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Type 2 Diabetes Mellitus, run by Solvay Pharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-course urinary sodium excretion calculated on the Day 1 of each study period (time frame: 0-6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2010.