A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus
BALANCE
Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12-Week Treatment With ASP1941 in Combination With Metformin in Patients With Type 2Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
2 other identifiers
interventional
343
6 countries
44
Brief Summary
Evaluate the efficacy, safety and tolerability of a 12-week treatment of 4 doses of ASP1941 compared to placebo in combination with metformin in adult patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Apr 2010
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2010
CompletedFirst Submitted
Initial submission to the registry
May 4, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 22, 2025
May 1, 2025
12 months
May 4, 2010
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c at Week 12
Baseline, 12 weeks
Secondary Outcomes (3)
Change from baseline in fasting plasma glucose (FPG) at Week 12
Baseline, 12 weeks
Achievement of target goal (HbA1c <7.0%) at Week 12
12 weeks
Achievement of target goal (HbA1c <6.5%) at Week 12
12 weeks
Study Arms (5)
ASP1941 lowest dose
EXPERIMENTALoral tablet
ASP1941 low dose
EXPERIMENTALoral tablet
ASP1941 high dose
EXPERIMENTALoral tablet
ASP1941 highest dose
EXPERIMENTALoral tablet
Placebo
PLACEBO COMPARATORoral tablet
Interventions
oral tablet
oral tablet
Eligibility Criteria
You may qualify if:
- Subject has been diagnosed with Diabetes Mellitus type 2 (T2DM) for at least 6 months
- Subject has inadequate glycemic control indicated by an HbA1c level between 7.0% and 9.5% at start of the run-in period at Visit 1 AND does not meet any of the FPG discontinuation criteria
- Subject has been on a stable dose of at least 1500 mg/day metformin monotherapy for at least 6 weeks prior to Visit 1
- Subject is on a stable diet and exercise program (for at least 6 weeks prior to Visit 1) and is willing to remain on this program for the duration of the study
- Subject has a body mass index (BMI) 20 - 45 kg/m2 at Visit 1
- Female subject of childbearing potential has a negative serum pregnancy test (human chorionic gonadotropin \[hCG\]) at Visit 1 and agrees to use an acceptable form of contraception throughout the duration of the study OR is at least 1 year post-menopausal (defined as amenorrhea for at least 1 year) or surgically sterile. Male study subjects should be advised to use a male condom in addition to having their partner use another acceptable method during the study and for 3 months after the last dose
You may not qualify if:
- Subject has any known complication of T2DM indicating a late disease state that in the investigator's opinion should preclude the subject from participation
- Subject has type 1 diabetes mellitus
- Subject is in need of insulin therapy or has received insulin within 3 months prior to Visit 1, with the exception of acute use of \<7 days
- Subject has a serum creatinine higher than upper limit of normal range at Visit 1
- Subject has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) higher than 3 times upper limit of normal range or has a total bilirubin more than 2 times upper limit of normal at Visit 1
- Subject has a urinary microalbumin/creatinine ratio above or equal to 300 mg/g at Visit 1
- Subject has a symptomatic urinary tract infection (UTI) or symptomatic genital infection at Visit 1 or during the placebo run-in period, including just prior to randomization at Visit 2
- Subject has persistent, uncontrolled severe hypertension as indicated by a systolic blood pressure \>180 mmHg or a diastolic blood pressure of \>110 mmHg taken in a sitting position after 5 minutes of rest on at least 2 measurements (within 30 minutes of each other) at Visit 1
- Subject has a significant cardiovascular disease, such as myocardial infarction or a vascular intervention (e.g. angioplasty or stent) within 3 months prior to Visit 1, or history of heart failure (New York Heart Association \[NYHA\] Class III IV)
- Subject is known to have hepatitis or be a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (enzyme linked immunosorbent assay \[ELISA\] plus confirmatory test), or is known positive for human immunodeficiency virus (HIV) HIV-1 and/or HIV 2
- Subject is currently receiving an excluded medication (loop-diuretics or systemic corticosteroids) or has received any other oral anti-diabetic drug except for metformin within 3 months prior to Visit 1
- Subject has history of lactic acidosis
- Subject has a history of drug or alcohol abuse/dependency within 12 months prior to Visit 1 as defined in the Diagnostic and Statistical Manual-IV (DSM-IV)
- Subject has had a malignancy in the last 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Female subject who is pregnant, lactating or pre-menopausal with positive serum pregnancy test (hCG) at Visit 1 or has an intention of becoming pregnant
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Los Angeles, California, 90036, United States
Unknown Facility
Coral Gables, Florida, 33134, United States
Unknown Facility
Hialeah, Florida, 33012, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Las Vegas, Nevada, 89106, United States
Unknown Facility
Baja, 6500, Hungary
Unknown Facility
Balatonfüred, 8230, Hungary
Unknown Facility
Budapest, 1036, Hungary
Unknown Facility
Budapest, 1076, Hungary
Unknown Facility
Gyöngyös, 3200, Hungary
Unknown Facility
Makó, 6900, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Zalaegerszeg, 8900, Hungary
Unknown Facility
Ancona, 60100, Italy
Unknown Facility
Milan, 20132, Italy
Unknown Facility
Siena, 53100, Italy
Unknown Facility
Chrzanów, 32-500, Poland
Unknown Facility
Katowice, 40-752, Poland
Unknown Facility
Krakow, 30-015, Poland
Unknown Facility
Krakow, 30-550, Poland
Unknown Facility
Kutno, 99-330, Poland
Unknown Facility
Lodz, 90-302, Poland
Unknown Facility
Lublin, 20-044, Poland
Unknown Facility
Warsaw, 03-003, Poland
Unknown Facility
Wroclaw, 50-127, Poland
Unknown Facility
Wroclaw, 50-349, Poland
Unknown Facility
Brasov, 500269, Romania
Unknown Facility
Brasov, 500365, Romania
Unknown Facility
Bucharest, 010492, Romania
Unknown Facility
Bucharest, 011234, Romania
Unknown Facility
Bucharest, 020275, Romania
Unknown Facility
Bucharest, 020475, Romania
Unknown Facility
Bucharest, 20045, Romania
Unknown Facility
Constanța, 900675, Romania
Unknown Facility
Craiova, 200642, Romania
Unknown Facility
Lasi, 700547, Romania
Unknown Facility
Ploieşti, 100018, Romania
Unknown Facility
Ploieşti, 100163, Romania
Unknown Facility
Sibiu, 550245, Romania
Unknown Facility
Sibiu, 550371, Romania
Unknown Facility
Birmingham, B15 2SQ, United Kingdom
Unknown Facility
Cambridgeshire, CB8 9PW, United Kingdom
Unknown Facility
Manchester, M15 6SX, United Kingdom
Unknown Facility
Reading, RG2 0TG, United Kingdom
Related Publications (1)
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.
PMID: 31606880DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ude Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2010
First Posted
May 5, 2010
Study Start
April 6, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
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/.