Type 2 Diabetes MellitusPhase 1NCT01165268
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United States.
Trial summary
It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of T2DM
- Must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin
- Subjects taking metformin, and/or sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration
- Must have a fasting plasma glucose concentration ≤ 200 mg/dl, and HbA1C ≤ 10%
- Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)
- Subjects with (eGFR ≥ 60 and ≤ 160 mL/min/1.73m² and urinary albumin excretion < 300 mg/g creatinine)
- Body Mass Index (BMI) of 18 to 38 kg/m²
- Men and women, ages 18 to 65 years, inclusive
Who cannot join
- Subjects with Type 1 Diabetes or uncontrolled Type 2 Diabetes Mellitus
- Subjects with T2DM with fasting plasma glucose > 200 mg/dL, healthy subjects with fasting plasma glucose > 105 mg/dL
- Subjects with T2DM with HbA1C > 10.0%, healthy subjects with HbA1C > 6.8%
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute For Clinical Research, Inc.
Chula Vista, California, 91911
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
It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- 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.
DapagliflozinDrug
Tablets, Oral, 10 mg, Once daily, 7 days
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin (T2DM) | Active comparator | Not described Receives: Drug: Dapagliflozin |
| Dapagliflozin (Healthy Subjects) | Active comparator | Not described Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
Measured: Before 7 days of oral administration of 10 mg of dapagliflozin
The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
Measured: After 7 days of oral administration of 10 mg of dapagliflozin
Secondary outcomes (4)
Splay of the glucose titration curve
Measured: Before 7 days of oral administration of 10 mg of dapagliflozin
Splay of the glucose titration curve
Measured: After 7 days of oral administration of 10 mg of dapagliflozin
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
Measured: Study Day 7
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
Measured: Study Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01165268
- Sponsor's protocol ID
- MB102-066
- Status last verified
- Nov 2016
- First submitted
- 16 Jul 2010
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 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
- NCT01165268
- Acronym / sponsor ID
- MB102-066
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Jul 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.
It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin (T2DM) | Active comparator | Drug: Dapagliflozin |
| Dapagliflozin (Healthy Subjects) | Active comparator | Drug: Dapagliflozin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of T2DM
- Must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin
- Subjects taking metformin, and/or sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration
- Must have a fasting plasma glucose concentration ≤ 200 mg/dl, and HbA1C ≤ 10%
- Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)
Key exclusion criteria (3 listed)
- Subjects with Type 1 Diabetes or uncontrolled Type 2 Diabetes Mellitus
- Subjects with T2DM with fasting plasma glucose > 200 mg/dL, healthy subjects with fasting plasma glucose > 105 mg/dL
- Subjects with T2DM with HbA1C > 10.0%, healthy subjects with HbA1C > 6.8%
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, 10 mg, Once daily, 7 days | Drug | Dapagliflozin (Healthy Subjects), Dapagliflozin (T2DM) |
Primary outcome
The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
Time frame: Before 7 days of oral administration of 10 mg of dapagliflozin
The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
Time frame: After 7 days of oral administration of 10 mg of dapagliflozin
4 secondary outcomes
Splay of the glucose titration curve
Time frame: Before 7 days of oral administration of 10 mg of dapagliflozin
Splay of the glucose titration curve
Time frame: After 7 days of oral administration of 10 mg of dapagliflozin
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
Time frame: Study Day 7
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
Time frame: Study Day 8
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 Nov 2016.
- MB102-066\_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 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 8 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 17 Nov 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?
The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin (time frame: Before 7 days of oral administration of 10 mg of dapagliflozin). 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 Nov 2016.