Type 2 Diabetes MellitusPhase 3NCT01672762
A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients
A Phase 3 study testing ipragliflozin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- ipragliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 7 sitesJapan
- Study dates
- 25 May 2012to 13 Apr 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
- Type 2 diabetes mellitus patients
- Subject is only on a diet and exercise program or has received a single antihyperglycemic agent or two antihyperglycemic agents (excluding insulin) with low dose (≤50% of the maximum dose of each recommended dosage)
- Subject has a HbA1c value (JDS value) between 6.5% and 9.5% and the difference of HbA1c values (JDS value) within ± 1.0%
- BMI 20.0 - 45.0 kg/m2
Who cannot join
- Type 1 Diabetes Mellitus
- Subject has received insulin within 12 weeks (84 days) before the study
- Subject has proliferative diabetic retinopathy
- Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
- Subject with obvious dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy
- Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 12 weeks (84 days). Subject has heart disease, cerebral vascular disease which, in the opinion of the principal investigator or the sub-investigator, may interfere with treatment or evaluation of safety of this study.
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- Female subject who is currently pregnant or lactating, or who is possibly pregnant
- Male and pre-menopausal Female subject who cannot use an appropriate contraception during the study
- Subject has a history of treatment with ASP1941
- Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies
- Subject has a serum creatinine value higher than upper limit of normal range
- Subject has a urinary microalbumin/ urinary creatinine ratio > 300 mg/g in urinalysis
- Subject has uncontrolled severe hypertension (subject whose systolic blood pressure is > 170 mmHg or diastolic blood pressure of > 95 mmHg measured in a sitting position after 5 minutes of rest
- Subject who is judged inappropriate for enrollment into the study by the principal investigator or the sub-investigator
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chūbu
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: Phase III Study of ASP1941 -A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.
Read the detailed description
Subjects will undergo the 6-week screening period before entering the 24-week treatment period and will receive ASP1941 before breakfast during the treatment period. All subjects will be followed for 4 weeks after study treatment is discontinued.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ipragliflozin
- Keywords
- glucose excretion, ipragliflozin, hypoglycemic agents, serum Insulin, diabetes mellitus, blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipragliflozinDrug
Also called ASP1941
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP1941 group | Experimental | oral Receives: Drug: ipragliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Secondary outcomes (6)
Change in fasting plasma glucose
Measured: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in fasting serum insulin
Measured: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in waist circumference
Measured: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in body weight
Measured: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in urine glucose
Measured: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study start25 May 2012
- Primary completion13 Apr 2013
- Study completion13 Apr 2013
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672762
- Sponsor's protocol ID
- 1941-CL-0122
- Status last verified
- Nov 2024
- First submitted
- 22 Aug 2012
- Last updated
- 8 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of ASP1941 -A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01672762
- Acronym / sponsor ID
- 1941-CL-0122
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- glucose excretion, ipragliflozin, hypoglycemic agents, serum Insulin, diabetes mellitus, blood glucose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 25 May 2012 (actual)
- Primary completion
- 13 Apr 2013 (actual)
- Study completion
- 13 Apr 2013 (actual)
- First posted
- 27 Aug 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.
This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.
Detailed description
Subjects will undergo the 6-week screening period before entering the 24-week treatment period and will receive ASP1941 before breakfast during the treatment period. All subjects will be followed for 4 weeks after study treatment is discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP1941 group | Experimental | Drug: ipragliflozinoral |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus patients
- Subject is only on a diet and exercise program or has received a single antihyperglycemic agent or two antihyperglycemic agents (excluding insulin) with low dose (≤50% of the maximum dose of each recommended dosage)
- Subject has a HbA1c value (JDS value) between 6.5% and 9.5% and the difference of HbA1c values (JDS value) within ± 1.0%
- BMI 20.0 - 45.0 kg/m2
Key exclusion criteria (14 listed)
- Type 1 Diabetes Mellitus
- Subject has received insulin within 12 weeks (84 days) before the study
- Subject has proliferative diabetic retinopathy
- Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
- Subject with obvious dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy
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 |
|---|---|---|
| ipragliflozinAlso: ASP1941oral | Drug | ASP1941 group |
Primary outcome
Change in HbA1c
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
6 secondary outcomes
Change in fasting plasma glucose
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in fasting serum insulin
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in waist circumference
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in body weight
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in urine glucose
Time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs
Time frame: 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 8 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.
Medical Director study director
Astellas Pharma Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ipragliflozin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 7 sites 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 4 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 8 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 7 sites 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. 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 (time frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week). 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 8 Nov 2024.