Diabetes Mellitus, Type 2Phase 1MADNCT00538174
Phase I Multiple-Ascending Dose (Japan)
A Phase 1 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2007to May 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese male and female subjects
- Ages 20 to 70 years old
- Established diagnosis of T2DM
- BMI < 32 kg/m2
- Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
- HbA1C 6.0 - 10.0%
Who cannot join
- Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment
- History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
- History of incontinence or bladder dysfunction including nocturia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dapagliflozin, placebo
- 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, once daily up, to 14 days
placeboDrug
Tablets, Oral, 0 mg, once daily, up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 2.5 mg Receives: Drug: Dapagliflozin |
| Arm 2 | Experimental | 10 mg Receives: Drug: Dapagliflozin |
| Arm 3 | Experimental | 20 mg Receives: Drug: Dapagliflozin |
| Arm 4 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs, vital signs & physical exam
Measured: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21
ECGs
Measured: scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21
Clinical labs
Measured: scr, Days -1, 2, 7, 12, 14, 15, 21
Urine safety markers
Measured: Days -1, 1, 14
Secondary outcomes (5)
24 hr PK blood & urine samples
Measured: Days 1 & 14
Serum glucose, serum insulin, serum c-peptide
Measured: Days -1, 1, 14
Serum fructosamine
Measured: Days -1, 14, 4 h
OGTT
Measured: Days -2, 13 (after 10 h fast)
24h urine
Measured: Days -1, 1 & 14 for glucose, creatinine & calcium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionMay 2008
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 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538174
- Sponsor's protocol ID
- MB102-025
- Acronym
- MAD
- Status last verified
- Mar 2015
- First submitted
- 1 Oct 2007
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kasichayanula S, Chang M, Hasegawa M, Liu X, Yamahira N, LaCreta FP, Imai Y, Boulton DW. Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium-glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Apr;13(4):357-65. doi: 10.1111/j.1463-1326.2011.01359.x.
PubMed 21226818
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects
- ClinicalTrials.gov ID
- NCT00538174
- Acronym / sponsor ID
- MAD / MB102-025
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 2 Oct 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 this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Dapagliflozin2.5 mg |
| Arm 2 | Experimental | Drug: Dapagliflozin10 mg |
| Arm 3 | Experimental | Drug: Dapagliflozin20 mg |
| Arm 4 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Japanese male and female subjects
- Ages 20 to 70 years old
- Established diagnosis of T2DM
- BMI < 32 kg/m2
- Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
Key exclusion criteria (3 listed)
- Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment
- History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
- History of incontinence or bladder dysfunction including nocturia
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, once daily up, to 14 days | Drug | Arm 1, Arm 2, Arm 3 |
| placeboTablets, Oral, 0 mg, once daily, up to 14 days | Drug | Arm 4 |
Primary outcome
AEs, vital signs & physical exam
Time frame: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21
ECGs
Time frame: scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21
Clinical labs
Time frame: scr, Days -1, 2, 7, 12, 14, 15, 21
Urine safety markers
Time frame: Days -1, 1, 14
5 secondary outcomes
24 hr PK blood & urine samples
Time frame: Days 1 & 14
Serum glucose, serum insulin, serum c-peptide
Time frame: Days -1, 1, 14
Serum fructosamine
Time frame: Days -1, 14, 4 h
OGTT
Time frame: Days -2, 13 (after 10 h fast)
24h urine
Time frame: Days -1, 1 & 14 for glucose, creatinine & calcium
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 23 Mar 2015.
- Results publication: PubMed 21226818Kasichayanula S, Chang M, Hasegawa M, Liu X, Yamahira N, LaCreta FP, Imai Y, Boulton DW. Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium-glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Apr;13(4):357-65. doi: 10.1111/j.1463-1326.2011.01359.x.
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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 K.K.
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 Mellitus, Type 2, run by AstraZeneca at 1 site in Japan.
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 6 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 23 Mar 2015. 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 Japan. 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. 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?
AEs, vital signs & physical exam (time frame: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21). The study lists 4 primary outcomes in all. 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 NCT00538174, 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 23 Mar 2015.