Type 2 Diabetes MellitusPhase 1NCT00930865
Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects
A Phase 1 study testing Bumetanide and Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United States.
Trial summary
To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Bumetanide and Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Sep 2009
- 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 as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized and men, ages 18 to 45
Who cannot join
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- Current smoker or recent (within 1 month) history of regular tobacco use
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- Abnormal urinalysis at screening
Show all 22Show fewer
- Glucosuria at screening
- Abnormal liver functions tests (ALT, AST or total bilirubin > 10 % ULN)
- Presence of edema on physical exam
- History of diabetes mellitus
- History of heart failure
- History of renal insufficiency
- History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
- Positive urine screen for drugs of abuse either at screening or before dosing
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
- History of allergy to SGLT2 inhibitors, bumetanide (or related compounds)
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- Prior exposure to dapagliflozin within 3 months of Day -1
- Exposure to any investigational drug or placebo within 4 weeks of Day -1
- Use of any prescription drugs within 4 weeks or over-the-counter acid controllers within 2 weeks prior to study drug administration
- Use of any other drugs, including over-the-counter medications within 1 week and herbal preparations, within 2 weeks prior to study drug administration
- Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Parallel-group, Multiple-Dose Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects
To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Bumetanide, Dapagliflozin
- 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.
BumetanideDrug
Also called Bumex
Tablets, Oral, 1 mg, Single Dose, 7 Days
DapagliflozinDrug
Also called BMS-512148
Tablets, Oral, 10 mg. Single Dose, 7 Days
| Study group | Role | What they receive |
|---|---|---|
| Bumetanide | Active comparator | Not described Receives: Drug: Bumetanide |
| Dapagliflozin | Active comparator | Not described Receives: Drug: Dapagliflozin |
| Bumetanide + Dapagliflozin | Active comparator | Not described Receives: Drug: Bumetanide; Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
Measured: 24 hours post-dose on Day 8 and 15
Secondary outcomes (2)
To assess the safety and tolerability of bumetanide and dapagliflozin following multiple oral doses of 1 mg bumetanide and 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone, in healthy subjects
Measured: during 14 days of dosing
Explore potential pharmacodynamic (serum/urine electrolytes) effects of bumetanide + dapagliflozin following multiple doses of 1 mg bumetanide + 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone
Measured: during 14 days of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT00930865
- Sponsor's protocol ID
- MB102-057
- Status last verified
- Oct 2016
- First submitted
- 30 Jun 2009
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilcox CS, Shen W, Boulton DW, Leslie BR, Griffen SC. Interaction Between the Sodium-Glucose-Linked Transporter 2 Inhibitor Dapagliflozin and the Loop Diuretic Bumetanide in Normal Human Subjects. J Am Heart Assoc. 2018 Feb 10;7(4):e007046. doi: 10.1161/JAHA.117.007046.
PubMed 29440005
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
- A Randomized, Open-Label, Parallel-group, Multiple-Dose Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00930865
- Acronym / sponsor ID
- MB102-057
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Jul 2009 (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.
To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bumetanide | Active comparator | Drug: Bumetanide |
| Dapagliflozin | Active comparator | Drug: Dapagliflozin |
| Bumetanide + Dapagliflozin | Active comparator | Drug: Bumetanide, Drug: Dapagliflozin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized and men, ages 18 to 45
Key exclusion criteria (22 listed)
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- Current smoker or recent (within 1 month) history of regular tobacco use
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
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 |
|---|---|---|
| BumetanideAlso: BumexTablets, Oral, 1 mg, Single Dose, 7 Days | Drug | Bumetanide, Bumetanide + Dapagliflozin |
| DapagliflozinAlso: BMS-512148Tablets, Oral, 10 mg. Single Dose, 7 Days | Drug | Bumetanide + Dapagliflozin, Dapagliflozin |
Primary outcome
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
Time frame: 24 hours post-dose on Day 8 and 15
2 secondary outcomes
To assess the safety and tolerability of bumetanide and dapagliflozin following multiple oral doses of 1 mg bumetanide and 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone, in healthy subjects
Time frame: during 14 days of dosing
Explore potential pharmacodynamic (serum/urine electrolytes) effects of bumetanide + dapagliflozin following multiple doses of 1 mg bumetanide + 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone
Time frame: during 14 days of dosing
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.
- Derived from this study: PubMed 29440005Wilcox CS, Shen W, Boulton DW, Leslie BR, Griffen SC. Interaction Between the Sodium-Glucose-Linked Transporter 2 Inhibitor Dapagliflozin and the Loop Diuretic Bumetanide in Normal Human Subjects. J Am Heart Assoc. 2018 Feb 10;7(4):e007046. doi: 10.1161/JAHA.117.007046.
- MB102-057\_redacted \_CSR \_synopsisLink 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 Bumetanide and Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United States.
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 22 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 United States. 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?
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs (time frame: 24 hours post-dose on Day 8 and 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930865, which also lists 1 linked publication.
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.