Diabetes Mellitus, Type 2Phase 2NCT01071850
A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing ipragliflozin and Metformin in people with Diabetes Mellitus, Type 2, run by Astellas Pharma Inc at 59 sites in 5 countries.
Trial summary
Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- ipragliflozin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 412 participants
- Where
- 59 sitesin 5 countries
- Study dates
- 3 Mar 2010to 11 Apr 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has been diagnosed with type 2 diabetes
- Subject has a HbA1c value between 6.8 and 9.5%
- Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
- Subject is on a stable diet and exercise program
- Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study
Who cannot join
- Subject has type 1 diabetes mellitus
- Subject is using insulin therapy
- Subject has a serum creatinine higher than upper limit of normal
- Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
- Subject has persistent, uncontrolled severe hypertension as indicated by a
- systolic blood pressure >180 mmHg or a diastolic blood pressure of
Show all 19Show fewer
- >110mmHg
- Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
- Subject is known to have hepatitis or be a carrier of hepatitis B surface
- antigen, hepatitis C virus antibody or is known positive for HIV1 and/or
- HIV2
- Subject has a history of lactic acidosis
- Subject has a history of drug and alcohol abuse/dependency within last 12
- months
- Subject has had a malignancy in the last 5 years, except for successfully
- treated basal or squamous cell carcinoma of the skin or of the cervix
- Subject has a symptomatic urinary tract infection or genital infection
- Female subject is lactating
- Subject has an unstable medical or psychiatric illness
Trial locations and contacts
59 sites in 5 countries.
59 sites in 5 countries
United States37 sites
CSRA Partners in Health, Inc.
Augusta, Georgia, 30909
Parkway Medical Center
Birmingham, Alabama, 35215
PAB Clinical Research
Brandon, Florida, 33511
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620
Punzi Medical Center
Carrollton, Texas, 75006
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209
Cedar Crosse Research Center
Chicago, Illinois, 60607
APEX Medical Research, AMR, Inc
Chicago, Illinois, 60616
Rapid Medical Research
Cleveland, Ohio, 44122
Expresscare Clinical Research
Colorado Springs, Colorado, 80909
Clinical Therapeutics Corp.
Coral Gables, Florida, 33131
Corpus Christi Family Wellness Center
Corpus Christi, Texas, 78414
Clinical Innovations, Inc.
Costa Mesa, California, 92626
Willamette Valley Clinical Studies
Eugene, Oregon, 97404
MediSphere Medical Research
Evansville, Indiana, 47714
Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522
Winston Technology Research, LLC
Haleyville, Alabama, 35565
A.G.A Clinical Trials DBA Neostart Group
Hialeah, Florida, 33012
Excel Clinical Research, LLC
Houston, Texas, 77081
Del Rosario Medical Clinic, Inc
Huntington Park, California, 90255
Holston Medical Group
Kingsport, Tennessee, 37660
Torrance Clinical Research
Lomita, California, 90717
Southwind Medical Specialist
Memphis, Tennessee, 38125
Desert Clinical Research
Mesa, Arizona, 85213
Suncoast Clinical Research
New Port Richey, Florida, 34652
Aspen Clinical Research
Orem, Utah, 84058
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020
Paul W. Davis, MD, PA
Pine Bluff, Arkansas, 71603
Prism Research
Saint Paul, Minnesota, 55114
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144
Cetero Research
San Antonio, Texas, 78229
San Diego Managed Care Group Clinical Research
San Diego, California, 92128
Southeastern Research Associates, Inc.
Taylors, South Carolina, 29687
Bay West Endocrinology
Towson, Maryland, 21204
Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.
Tucker, Georgia, 30084
Integris Family Care
Yukon, Oklahoma, 73099
Primecare of Southeastern Ohio, Inc.
Zanesville, Ohio, 43701
Colombia6 sites
BIOMELAB
Barranquilla
Centro de Reumatologia y ortopedia
Barranquilla
Fundacion de Caribe para le Investigacion Biomedica
Barranquilla
Dexa Diad Servicios Medicos
Bogotá
School of Medicine University of Rosario
Bogotá
Fundacion Cardiovascular de Columbia
Floridablanca Santander
India6 sites
Diacon Hospital
Bangalore, 560010
Hormone Care and Research Centre
Ghaziabad, 201002
TOTALL Diabetes Hormone Institute Pvt.Ltd.
Indore, 452001
S R Kalla Memorial Gastro & General Hospital
Jaipur, 302001
Bride, Bharti Hospital
Karnāl, 132001
Amrita Institute of Medical Sciences and Research Centre, AIMS
Kerala, 682041
Mexico6 sites
Unidad Metabólica y Cardiovascular, SC.
Cuernavaca, 62250
Instituto Jaliscience de Investigacion Clinica
Guadalajara, 44100
Torre Medica Providencia
Guadalajara, 44670
Medical Care and Research
Mérida, 97070
CEDIME, Instituto Vascular
Mérida, 97129
Hospital Universitario Dr. Eleuterio Gonzalez
Monterrey, 66460
Philippines4 sites
Cebu Doctors' University Hospital
Cebu, 6000
St. Paul's Hospital
Iloilo City, 5000
Amang Rodriguez Memorial Medical Center
Marikina City, 1800
San Juan De Dios Hospital
Pasay, 1300
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus
Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- ipragliflozin, Metformin, Placebo
- Keywords
- ASP1941, Metformin, Type 2 diabetes, diabetes
- 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 tablet
MetforminDrug
oral tablet
PlaceboDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| ASP1941 lowest dose | Experimental | oral tablet Receives: Drug: ipragliflozin |
| ASP1941 low dose | Experimental | oral tablet Receives: Drug: ipragliflozin |
| ASP1941 high dose | Experimental | oral tablet Receives: Drug: ipragliflozin |
| ASP1941 highest dose | Experimental | oral tablet Receives: Drug: ipragliflozin |
| Metformin | Active comparator | oral tablet Receives: Drug: Metformin |
| Placebo | Placebo comparator | oral tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in Hemoglobin A1c (HbA1c)
Measured: 12 weeks
Secondary outcomes (3)
Mean change from baseline in fasting plasma glucose (FPG)
Measured: 12 weeks
Proportion of subjects achieving target goal of HbA1c <7.0%
Measured: 12 weeks
Proportion of subjects achieving target goal of HbA1c <6.5%
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 posted19 Feb 2010 (estimated)
- Study start3 Mar 2010
- Primary completion11 Apr 2011
- Study completion11 Apr 2011
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 Mellitus, Type 2Studies 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
- 412 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 Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071850
- Sponsor's protocol ID
- 1941-CL-0004
- Status last verified
- May 2025
- First submitted
- 18 Feb 2010
- Last updated
- 22 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 31606880Fonseca VA, Ferrannini E, Wilding JP, Wilpshaar W, Dhanjal P, Ball G, Klasen S. Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus. J Diabetes Complications. 2013 May-Jun;27(3):268-73. doi: 10.1016/j.jdiacomp.2012.11.005. Epub 2012 Dec 29.
PubMed 23276620
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01071850
- Acronym / sponsor ID
- 1941-CL-0004
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- ASP1941, Metformin, Type 2 diabetes, diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2010 (actual)
- Primary completion
- 11 Apr 2011 (actual)
- Study completion
- 11 Apr 2011 (actual)
- First posted
- 19 Feb 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.
Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult 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
- 6
| Arm | Type | Receives |
|---|---|---|
| ASP1941 lowest dose | Experimental | Drug: ipragliflozinoral tablet |
| ASP1941 low dose | Experimental | Drug: ipragliflozinoral tablet |
| ASP1941 high dose | Experimental | Drug: ipragliflozinoral tablet |
| ASP1941 highest dose | Experimental | Drug: ipragliflozinoral tablet |
| Metformin | Active comparator | Drug: Metforminoral tablet |
| Placebo | Placebo comparator | Drug: Placebooral tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has been diagnosed with type 2 diabetes
- Subject has a HbA1c value between 6.8 and 9.5%
- Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
- Subject is on a stable diet and exercise program
- Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study
Key exclusion criteria (19 listed)
- Subject has type 1 diabetes mellitus
- Subject is using insulin therapy
- Subject has a serum creatinine higher than upper limit of normal
- Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
- Subject has persistent, uncontrolled severe hypertension as indicated by a
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 tablet | Drug | ASP1941 high dose, ASP1941 highest dose, ASP1941 low dose, ASP1941 lowest dose |
| Metforminoral tablet | Drug | Metformin |
| Placebooral tablet | Drug | Placebo |
Primary outcome
Mean change from baseline in Hemoglobin A1c (HbA1c)
Time frame: 12 weeks
3 secondary outcomes
Mean change from baseline in fasting plasma glucose (FPG)
Time frame: 12 weeks
Proportion of subjects achieving target goal of HbA1c <7.0%
Time frame: 12 weeks
Proportion of subjects achieving target goal of HbA1c <6.5%
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 22 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.
- Derived from this study: PubMed 23276620Fonseca VA, Ferrannini E, Wilding JP, Wilpshaar W, Dhanjal P, Ball G, Klasen S. Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus. J Diabetes Complications. 2013 May-Jun;27(3):268-73. doi: 10.1016/j.jdiacomp.2012.11.005. Epub 2012 Dec 29.
- 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 Global Development
59 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ipragliflozin and Metformin in people with Diabetes Mellitus, Type 2, run by Astellas Pharma Inc at 59 sites in 5 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 19 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 22 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 59 sites in United States, Colombia, India, Mexico, Philippines. 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?
Mean change from baseline in Hemoglobin A1c (HbA1c) (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 NCT01071850, 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 22 May 2025.