Type 2 Diabetes MellitusPhase 1NCT00566865
Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil
A Phase 1 study testing gemfibrozil in people with Type 2 Diabetes Mellitus, run by Elixir Pharmaceuticals.
Trial summary
The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- gemfibrozil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Dec 2007
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoker
- Body mass index (BMI) of 19-28 kg/m2
- no relevant food allergies
Who cannot join
- any subject for whom gemfibrozil is contraindicated
- any subject with a history of hypoglycemia or who tend to get easily hypoglycemic
- clinically significant history of or current abnormality or disease of any organ system
About this study
Official title: A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers
The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- placebo for gemfibrozil, gemfibrozil
- 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.
placebo for gemfibrozilDrug
mitiglinide + placebo for gemfibrozil 600 mg bid
gemfibrozilDrug
Mitiglinide + 600 mg gemfibrozil bid
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | mitiglinide + gemfibrozil Receives: Drug: gemfibrozil |
| 1 | Placebo comparator | mitiglinide + placebo for gemfibrozil Receives: Drug: placebo for gemfibrozil |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics of mitiglinide
Measured: 3 days of treatment with gemfibrozil
pharmacodynamics of mitiglinide
Measured: 3 days of treatment with gemfibrozil
Secondary outcomes (1)
safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil
Measured: 3 days of treatment with gemfibrozil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionDec 2007
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elixir Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Erin Nulf, RN, BSN, Study director, Quintiles Phase I Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566865
- Sponsor's protocol ID
- EX-1510-CT-002
- Status last verified
- Feb 2009
- First submitted
- 3 Dec 2007
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00566865
- Acronym / sponsor ID
- EX-1510-CT-002
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Elixir PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Dec 2007 (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.
The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: gemfibrozilmitiglinide + gemfibrozil |
| 1 | Placebo comparator | Drug: placebo for gemfibrozilmitiglinide + placebo for gemfibrozil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- non-smoker
- Body mass index (BMI) of 19-28 kg/m2
- no relevant food allergies
Key exclusion criteria (3 listed)
- any subject for whom gemfibrozil is contraindicated
- any subject with a history of hypoglycemia or who tend to get easily hypoglycemic
- clinically significant history of or current abnormality or disease of any organ system
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 |
|---|---|---|
| placebo for gemfibrozilmitiglinide + placebo for gemfibrozil 600 mg bid | Drug | 1 |
| gemfibrozilMitiglinide + 600 mg gemfibrozil bid | Drug | 2 |
Primary outcome
pharmacokinetics of mitiglinide
Time frame: 3 days of treatment with gemfibrozil
pharmacodynamics of mitiglinide
Time frame: 3 days of treatment with gemfibrozil
1 secondary outcome
safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil
Time frame: 3 days of treatment with gemfibrozil
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 18 Feb 2009.
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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.
Erin Nulf, RN, BSN study director
Quintiles Phase I Services
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gemfibrozil in people with Type 2 Diabetes Mellitus, run by Elixir Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
pharmacokinetics of mitiglinide (time frame: 3 days of treatment with gemfibrozil). 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 18 Feb 2009.