Diabetes Mellitus, Type 2Phase 1NCT00562250
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
A Phase 1 study testing Dapagliflozin, Glimepiride and Dapagliflozin + Glimepiride in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 1 site in Argentina.
Trial summary
The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dapagliflozin, Glimepiride and Dapagliflozin + Glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteArgentina
- Study dates
- May 2008to Aug 2008
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with BMI of 18-32 kg/m2
Who cannot join
- Abnormal physical or lab findings
- Allergies to any sulfonylurea or related compounds
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dapagliflozin, Glimepiride, Dapagliflozin + Glimepiride
- 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.
DapagliflozinDrug
Tablets, Oral, 20 mg, once daily, single dose
GlimepirideDrug
Tablets, Oral, 4 mg, once daily, single dose
Dapagliflozin + GlimepirideDrug
Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Dapagliflozin |
| Arm 2 | Active comparator | Not described Receives: Drug: Glimepiride |
| Arm 3 | Active comparator | Not described Receives: Drug: Dapagliflozin + Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together
Measured: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose
Secondary outcomes (2)
Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride
Measured: for 72 hours after each administered dose
Recorded adverse events
Measured: for 72 hours after each administered dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562250
- Sponsor's protocol ID
- MB102-016
- Status last verified
- Oct 2016
- First submitted
- 21 Nov 2007
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00562250
- Acronym / sponsor ID
- MB102-016
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Nov 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 purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Dapagliflozin |
| Arm 2 | Active comparator | Drug: Glimepiride |
| Arm 3 | Active comparator | Drug: Dapagliflozin + Glimepiride |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects with BMI of 18-32 kg/m2
Key exclusion criteria (2 listed)
- Abnormal physical or lab findings
- Allergies to any sulfonylurea or related compounds
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 |
|---|---|---|
| DapagliflozinTablets, Oral, 20 mg, once daily, single dose | Drug | Arm 1 |
| GlimepirideTablets, Oral, 4 mg, once daily, single dose | Drug | Arm 2 |
| Dapagliflozin + GlimepirideTablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose | Drug | Arm 3 |
Primary outcome
Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together
Time frame: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose
2 secondary outcomes
Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride
Time frame: for 72 hours after each administered dose
Recorded adverse events
Time frame: for 72 hours after each administered dose
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 Oct 2016.
- MB102-016 \_CSR \_synosisLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 testing Dapagliflozin, Glimepiride and Dapagliflozin + Glimepiride in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 1 site in Argentina.
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 1 inclusion and 2 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 17 Oct 2016. 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 Argentina. 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. 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?
Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together (time frame: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose). 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 Oct 2016.