Type II Diabetes MellitusPhase 3NCT01505426
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
A Phase 3 study testing ASP1941 and metformin in people with Type II Diabetes Mellitus, run by Astellas Pharma Inc at 12 sites in 2 countries.
Trial summary
To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- ASP1941 and metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 28 Nov 2011to 14 Jan 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
- Stable diet and exercise program for at least 8 weeks before the study
- On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
- BMI of 20.0 to 45.0 kg/m2
- A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose
Who cannot join
- Type 1 diabetes mellitus
- Proliferative diabetic retinopathy
- Receiving insulin within 12 weeks prior to the study
- History of clinically significant renal disease(s)
- Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
- Urinary tract infection or genital infection
Show all 14Show fewer
- Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
- History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
- Severe infection, serious trauma, or perioperative subject
- Known or suspected hypersensitivity to ASP1941
- History of treatment with ASP1941
- Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
- Serum creatinine value exceeding the upper limit of normal range
- Urinary microalbumin/urinary creatinine ratio >300 mg/g
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
South Korea8 sites
Study site
Busan
Study site
Daegu
Study site
Daejeon
Study site
Gwangju
Study site
Incheon
Study site
Jeonju
Study site
Seoul
Study site
Wŏnju
Taiwan4 sites
Study site
Kaohsiung City
Study site
Taichung
Study site
Tainan
Study site
Taipei
About this study
Official title: A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- ASP1941, metformin, Placebo
- Keywords
- ASP1941, ipragliflozin, urine glucose, metformin, plasma glucose
- Medical subject headings
- Diabetes Mellitus, Type 2, Glycosuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1941Drug
Also called ipragliflozin
oral
metforminDrug
oral, concomitant use
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP1941 group | Experimental | ASP1941 + metformin Receives: Drug: ASP1941; Drug: metformin |
| placebo group | Placebo comparator | placebo + metformin Receives: Drug: metformin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to end of treatment
Measured: Baseline and up to 24 weeks
Secondary outcomes (5)
Change in fasting plasma glucose level
Measured: Baseline and up to 24 weeks
Change in fasting serum insulin level
Measured: Baseline and up to 24 weeks
Change in body weight
Measured: Baseline and up to 24 weeks
Change in waist circumference
Measured: Baseline and up to 24 weeks
Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG
Measured: For 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study start28 Nov 2011
- Primary completion14 Jan 2013
- Study completion14 Jan 2013
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 II Diabetes MellitusStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505426
- Sponsor's protocol ID
- 1941-CL-2004
- Status last verified
- Nov 2024
- First submitted
- 4 Jan 2012
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
PubMed 31606880
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
- ClinicalTrials.gov ID
- NCT01505426
- Acronym / sponsor ID
- 1941-CL-2004
- Conditions
- Type II Diabetes Mellitus
- Keywords
- ASP1941, ipragliflozin, urine glucose, metformin, plasma glucose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2011 (actual)
- Primary completion
- 14 Jan 2013 (actual)
- Study completion
- 14 Jan 2013 (actual)
- First posted
- 6 Jan 2012 (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 compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP1941 group | Experimental | Drug: ASP1941, Drug: metforminASP1941 + metformin |
| placebo group | Placebo comparator | Drug: metformin, Drug: Placeboplacebo + metformin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
- Stable diet and exercise program for at least 8 weeks before the study
- On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
- BMI of 20.0 to 45.0 kg/m2
- A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose
Key exclusion criteria (14 listed)
- Type 1 diabetes mellitus
- Proliferative diabetic retinopathy
- Receiving insulin within 12 weeks prior to the study
- History of clinically significant renal disease(s)
- Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
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 |
|---|---|---|
| ASP1941Also: ipragliflozinoral | Drug | ASP1941 group |
| metforminoral, concomitant use | Drug | ASP1941 group, placebo group |
| Placebooral | Drug | placebo group |
Primary outcome
Change in HbA1c from baseline to end of treatment
Time frame: Baseline and up to 24 weeks
5 secondary outcomes
Change in fasting plasma glucose level
Time frame: Baseline and up to 24 weeks
Change in fasting serum insulin level
Time frame: Baseline and up to 24 weeks
Change in body weight
Time frame: Baseline and up to 24 weeks
Change in waist circumference
Time frame: Baseline and up to 24 weeks
Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG
Time frame: For 24 weeks
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 12 Nov 2024.
- Derived from this study: PubMed 31606880Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Use Central Contact study chair
Astellas Pharma Inc
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASP1941 and metformin in people with Type II Diabetes Mellitus, run by Astellas Pharma Inc at 12 sites in 2 countries.
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 14 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in HbA1c from baseline to end of treatment (time frame: Baseline and up to 24 weeks). 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 NCT01505426, 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 12 Nov 2024.