Diabetes MellitusPhase 2NCT00621868
A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus
A Phase 2 study testing ipragliflozin in people with Diabetes Mellitus, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- ipragliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 361 participants
- Where
- 8 sitesJapan
- Study dates
- 26 Mar 2008to 14 Mar 2009
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of type 2 diabetes mellitus
- Fasting serum C-peptide level > 0.6 ng/mL
- HbA1c between 7.0 and 10.0%
- Body Mass Index between 20 and 45 kg/m2
Who cannot join
- Serum creatinine > upper limit of normal
- Proteinuria (albumin/creatinine ratio > 300 mg/g)
- Dysuria and/or urinary tract infection
- Significant renal, hepatic or cardiovascular diseases
- Ketosis
- Hypertension
- Severe gastrointestinal diseases
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaidou
Study site
Kansai
Study site
Kantou
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus
- Conditions
- Diabetes Mellitus
- Being tested
- ipragliflozin, Placebo
- Keywords
- Diabetes Mellitus, Type 2, ASP1941
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipragliflozinDrug
Also called ASP1941
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lowest dose Receives: Drug: ipragliflozin |
| 2 | Experimental | Low-middle dose Receives: Drug: ipragliflozin |
| 3 | Experimental | High-middle dose Receives: Drug: ipragliflozin |
| 4 | Experimental | Highest dose Receives: Drug: ipragliflozin |
| 5 | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c level
Measured: 12 weeks
Secondary outcomes (2)
Blood glucose level
Measured: 12 Weeks
Safety
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study start26 Mar 2008
- Primary completion14 Mar 2009
- Study completion14 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621868
- Sponsor's protocol ID
- 1941-CL-0103
- Status last verified
- Nov 2024
- First submitted
- 13 Feb 2008
- 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 31606880Kashiwagi A, Kazuta K, Yoshida S, Nagase I. Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2014 Jul;5(4):382-91. doi: 10.1111/jdi.12156. Epub 2013 Nov 28.
PubMed 25411597
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
- ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00621868
- Acronym / sponsor ID
- 1941-CL-0103
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Type 2, ASP1941
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2008 (actual)
- Primary completion
- 14 Mar 2009 (actual)
- Study completion
- 14 Mar 2009 (actual)
- First posted
- 22 Feb 2008 (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 objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients 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
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ipragliflozinLowest dose |
| 2 | Experimental | Drug: ipragliflozinLow-middle dose |
| 3 | Experimental | Drug: ipragliflozinHigh-middle dose |
| 4 | Experimental | Drug: ipragliflozinHighest dose |
| 5 | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established diagnosis of type 2 diabetes mellitus
- Fasting serum C-peptide level > 0.6 ng/mL
- HbA1c between 7.0 and 10.0%
- Body Mass Index between 20 and 45 kg/m2
Key exclusion criteria (7 listed)
- Serum creatinine > upper limit of normal
- Proteinuria (albumin/creatinine ratio > 300 mg/g)
- Dysuria and/or urinary tract infection
- Significant renal, hepatic or cardiovascular diseases
- Ketosis
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 | 1, 2, 3, 4 |
| PlaceboOral | Drug | 5 |
Primary outcome
HbA1c level
Time frame: 12 weeks
2 secondary outcomes
Blood glucose level
Time frame: 12 Weeks
Safety
Time frame: 12 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.
- Derived from this study: PubMed 25411597Kashiwagi A, Kazuta K, Yoshida S, Nagase I. Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2014 Jul;5(4):382-91. doi: 10.1111/jdi.12156. Epub 2013 Nov 28.
- 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.
Central Contact study chair
Astellas Pharma Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ipragliflozin in people with Diabetes Mellitus, run by Astellas Pharma Inc at 8 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 7 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 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
HbA1c level (time frame: 12 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 NCT00621868, which also lists 2 linked publications.
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.