Type 2 Diabetes MellitusPhase 3NCT01242215
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Sulfonylurea in Type 2 Diabetic Patients
A Phase 3 study testing ipragliflozin and Sulfonylurea in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus. 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 and Sulfonylurea
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 7 sitesJapan
- Study dates
- 17 Sep 2010to 25 Apr 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
- Type 2 diabetic patients receiving with sulfonylurea mono-therapy for at least 4 weeks
- HbA1c value between 7.0 and 9.5%
- Body Mass Index (BMI) 20.0 - 45.0 kg/m2
Who cannot join
- Type 1 diabetes mellitus patients
- Serum creatinine > upper limit of normal
- Proteinuria (albumin/creatinine ratio > 300mg/g)
- Dysuria and/or urinary tract infection, genital infection
- Significant renal, hepatic or cardiovascular diseases
- Severe gastrointestinal diseases
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
Study site
Tōhoku
About this study
Official title: A Phase III Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Sulfonylurea in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Alone
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus.
Read the detailed description
This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ipragliflozin, Placebo, Sulfonylurea
- Keywords
- Diabetes mellitus, sulfonylurea, ASP1941
- 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.
ipragliflozinDevice
Also called ASP1941
oral
PlaceboDrug
oral
SulfonylureaDrug
Also called Glibenclamide, Gliclazide, Glimepiride
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP group | Experimental | ASP1941 and sulfonylurea Receives: Device: ipragliflozin; Drug: Sulfonylurea |
| Placebo group | Placebo comparator | placebo and sulfonylurea Receives: Drug: Placebo; Drug: Sulfonylurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Measured: Baseline and for 24 weeks
Secondary outcomes (3)
Change from baseline in fasting plasma glucose
Measured: Baseline and for 24 weeks
Change from baseline in fasting serum insulin
Measured: Baseline and for 24 weeks
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
Measured: for 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study start17 Sep 2010
- Primary completion25 Apr 2012
- Study completion25 Apr 2012
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 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
- NCT01242215
- Sponsor's protocol ID
- 1941-CL-0109
- Status last verified
- May 2025
- First submitted
- 15 Nov 2010
- Last updated
- 30 May 2025
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Sulfonylurea in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Alone
- ClinicalTrials.gov ID
- NCT01242215
- Acronym / sponsor ID
- 1941-CL-0109
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes mellitus, sulfonylurea, ASP1941
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2010 (actual)
- Primary completion
- 25 Apr 2012 (actual)
- Study completion
- 25 Apr 2012 (actual)
- First posted
- 16 Nov 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.
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus.
Detailed description
This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.
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 |
|---|---|---|
| ASP group | Experimental | Device: ipragliflozin, Drug: SulfonylureaASP1941 and sulfonylurea |
| Placebo group | Placebo comparator | Drug: Placebo, Drug: Sulfonylureaplacebo and sulfonylurea |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetic patients receiving with sulfonylurea mono-therapy for at least 4 weeks
- HbA1c value between 7.0 and 9.5%
- Body Mass Index (BMI) 20.0 - 45.0 kg/m2
Key exclusion criteria (6 listed)
- Type 1 diabetes mellitus patients
- Serum creatinine > upper limit of normal
- Proteinuria (albumin/creatinine ratio > 300mg/g)
- Dysuria and/or urinary tract infection, genital infection
- Significant renal, hepatic or cardiovascular diseases
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 | Device | ASP group |
| Placebooral | Drug | Placebo group |
| SulfonylureaAlso: Glibenclamide, Gliclazide, Glimepirideoral | Drug | ASP group, Placebo group |
Primary outcome
Change from baseline in HbA1c
Time frame: Baseline and for 24 weeks
3 secondary outcomes
Change from baseline in fasting plasma glucose
Time frame: Baseline and for 24 weeks
Change from baseline in fasting serum insulin
Time frame: Baseline and for 24 weeks
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
Time frame: for 52 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 30 May 2025.
- 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
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 and Sulfonylurea 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 3 inclusion and 6 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 30 May 2025. 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. 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 from baseline in HbA1c (time frame: Baseline and for 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 NCT01242215, 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 30 May 2025.