Type II Diabetes MellitusPhase 3NCT01514838
A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
A Phase 3 study testing ASP1941 and acarbose in people with Type II Diabetes Mellitus, run by Astellas Pharma Inc at 15 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety 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 acarbose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 23 Apr 2012to 19 Oct 2012
- 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 6 weeks before the study
- for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy
- BMI of 20.0 to 45.0 kg/m2
- for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
- for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
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, acarbose or other alpha-GI
- 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
15 sites in 2 countries.
15 sites in 2 countries
South Korea8 sites
Study site
Busan
Study site
Daegu
Study site
Daejeon
Study site
Gwangju
Study site
Incheon
Study site
Seongnam
Study site
Seoul
Study site
Wŏnju
Taiwan7 sites
Study site
Changha
Study site
Chiayi City
Study site
Kaohsiung City
Study site
Taichung
Study site
Tainan
Study site
Taipei
Study site
Taoyuan
About this study
Official title: A Phase III, Double-Blind, Randomized, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.
Read the detailed description
This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the ASP1941 or the acarbose group. Subjects will take the study drug under the double-blind condition in the treatment period. After completion of the study drug administration, a follow-up period will be provided.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- ASP1941, acarbose, Placebo
- Keywords
- urine glucose, ipragliflozin, plasma glucose, ASP1941
- 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
acarboseDrug
oral
PlaceboDrug
oral, used only during placebo run-in period
| Study group | Role | What they receive |
|---|---|---|
| 1941 group | Experimental | Once daily over a 24-week treatment period Receives: Drug: ASP1941; Drug: Placebo |
| acarbose group | Active comparator | Once daily over a 24-week treatment period Receives: Drug: acarbose; 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 body 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 posted23 Jan 2012 (estimated)
- Study start23 Apr 2012
- Primary completion19 Oct 2012
- Study completion19 Oct 2012
Why it stopped: Discontinued due to company's strategic reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 46 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
- NCT01514838
- Sponsor's protocol ID
- 1941-CL-2003
- Status last verified
- Nov 2024
- First submitted
- 18 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/.
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, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01514838
- Acronym / sponsor ID
- 1941-CL-2003
- Conditions
- Type II Diabetes Mellitus
- Keywords
- urine glucose, ipragliflozin, plasma glucose, ASP1941
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued due to company's strategic reason
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2012 (actual)
- Primary completion
- 19 Oct 2012 (actual)
- Study completion
- 19 Oct 2012 (actual)
- First posted
- 23 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.
The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.
Detailed description
This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the ASP1941 or the acarbose group. Subjects will take the study drug under the double-blind condition in the treatment period. After completion of the study drug administration, a follow-up period will be provided.
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 |
|---|---|---|
| 1941 group | Experimental | Drug: ASP1941, Drug: PlaceboOnce daily over a 24-week treatment period |
| acarbose group | Active comparator | Drug: acarbose, Drug: PlaceboOnce daily over a 24-week treatment period |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
- stable diet and exercise program for at least 6 weeks before the study
- for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy
- BMI of 20.0 to 45.0 kg/m2
- for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
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 | 1941 group |
| acarboseoral | Drug | acarbose group |
| Placebooral, used only during placebo run-in period | Drug | 1941 group, acarbose 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 body 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 was stopped early (reason given: Discontinued due to company's strategic reason). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- 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
15 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 acarbose in people with Type II Diabetes Mellitus, run by Astellas Pharma Inc at 15 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 6 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: stopped early, 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 15 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. 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 was stopped early (reason given: Discontinued due to company's strategic reason). 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?
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?
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.