Diabetes, NOSPhase 1MOANCT00726505
Renal Mechanism of Action/Splay vs. TmG
A Phase 1 study testing Dapagliflozin in people with Diabetes, NOS, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, NOS
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects
- Age 18 to 65 years
- BMI 18 to 35 kg/m2
- Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin
- No evidence of impaired renal function
Who cannot join
- Unwilling or unable to use an acceptable method of birth control
- Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B
- Exposure to insulin
- Use of exclusionary concomitant medications
- Evidence of significant kidney disease or any other significant medical or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Texas Health Center At San Antonio
San Antonio, Texas, 78229
About this study
Official title: Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus
- Conditions
- Diabetes, NOS
- Being tested
- Dapagliflozin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called BMS-512148
Tablets, Oral, Once Daily, up to 29 days:
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Subjects with T2DM - Dapagliflozin 5 mg Receives: Drug: Dapagliflozin |
| Group 2 | Active comparator | Subjects with T2DM - Dapagliflozin 20 mg Receives: Drug: Dapagliflozin |
| Group 3 | Active comparator | Healthy Subjects - Dapagliflozin 20 mg Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in urinary glucose excretion dynamics
Measured: after 7 days of treatment
Secondary outcomes (3)
Differences in urinary glucose between healthy and diabetic subjects
Measured: at 7 days
Changes in liver glucose production
Measured: at one day
Glucose effects on tubular markers
Measured: at one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, NOSStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT00726505
- Sponsor's protocol ID
- MB102-020
- Acronym
- MOA
- Status last verified
- Oct 2016
- First submitted
- 30 Jul 2008
- 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
- Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00726505
- Acronym / sponsor ID
- MOA / MB102-020
- Conditions
- Diabetes, NOS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 1 Aug 2008 (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 this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: DapagliflozinSubjects with T2DM - Dapagliflozin 5 mg |
| Group 2 | Active comparator | Drug: DapagliflozinSubjects with T2DM - Dapagliflozin 20 mg |
| Group 3 | Active comparator | Drug: DapagliflozinHealthy Subjects - Dapagliflozin 20 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects
- Age 18 to 65 years
- BMI 18 to 35 kg/m2
- Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin
- No evidence of impaired renal function
Key exclusion criteria (5 listed)
- Unwilling or unable to use an acceptable method of birth control
- Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B
- Exposure to insulin
- Use of exclusionary concomitant medications
- Evidence of significant kidney disease or any other significant medical or psychiatric disorder
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 |
|---|---|---|
| DapagliflozinAlso: BMS-512148Tablets, Oral, Once Daily, up to 29 days: | Drug | Group 1, Group 2, Group 3 |
Primary outcome
The change in urinary glucose excretion dynamics
Time frame: after 7 days of treatment
3 secondary outcomes
Differences in urinary glucose between healthy and diabetic subjects
Time frame: at 7 days
Changes in liver glucose production
Time frame: at one day
Glucose effects on tubular markers
Time frame: at one day
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- MB102020 \_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 Dapagliflozin in people with Diabetes, NOS, 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 5 inclusion and 5 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: stopped early, 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 was stopped early. Results are not available in the source record.
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?
The change in urinary glucose excretion dynamics (time frame: after 7 days of treatment). 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.