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Type 2 Diabetes MellitusPhase 2BALANCENCT01117584

A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus

A Phase 2 study testing ipragliflozin and Metformin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 44 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
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
343 participants
Where
44 sitesin 6 countries
Study dates
6 Apr 2010to 1 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 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

Who cannot join

  • 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
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  • 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
  • Subject has an unstable medical or psychiatric illness
  • Subject has known or suspected hypersensitivity to ASP1941 or any components of the formulations used
  • Subject has previously received ASP1941
  • Subject is concurrently participating in another drug study or has received an investigational drug within 30 days (or the limit set by national law, whichever is longer) prior to Visit 1
  • Subject has any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety or completion of this study
  • In the investigator's judgment, the subject is unable to adhere to the treatment regimen, protocol procedures or study requirements

Trial locations and contacts

44 sites in 6 countries.

44 sites in 6 countries

Romania14 sites

  • Study site

    Brasov, 500269

  • Study site

    Brasov, 500365

  • Study site

    Bucharest, 010492

  • Study site

    Bucharest, 011234

  • Study site

    Bucharest, 020275

  • Study site

    Bucharest, 020475

  • Study site

    Bucharest, 20045

  • Study site

    Constanța, 900675

  • Study site

    Craiova, 200642

  • Study site

    Lasi, 700547

  • Study site

    Ploieşti, 100018

  • Study site

    Ploieşti, 100163

  • Study site

    Sibiu, 550245

  • Study site

    Sibiu, 550371

Other trials in Romania

Poland10 sites

  • Study site

    Chrzanów, 32-500

  • Study site

    Katowice, 40-752

  • Study site

    Krakow, 30-015

  • Study site

    Krakow, 30-550

  • Study site

    Kutno, 99-330

  • Study site

    Lodz, 90-302

  • Study site

    Lublin, 20-044

  • Study site

    Warsaw, 03-003

  • Study site

    Wroclaw, 50-127

  • Study site

    Wroclaw, 50-349

Other trials in Poland

Hungary8 sites

  • Study site

    Baja, 6500

  • Study site

    Balatonfüred, 8230

  • Study site

    Budapest, 1036

  • Study site

    Budapest, 1076

  • Study site

    Gyöngyös, 3200

  • Study site

    Makó, 6900

  • Study site

    Nyíregyháza, 4400

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

United States5 sites

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Los Angeles, California, 90036

Other trials in United States

United Kingdom4 sites

  • Study site

    Birmingham, B15 2SQ

  • Study site

    Cambridgeshire, CB8 9PW

  • Study site

    Manchester, M15 6SX

  • Study site

    Reading, RG2 0TG

Other trials in United Kingdom

Italy3 sites

  • Study site

    Ancona, 60100

  • Study site

    Milan, 20132

  • Study site

    Siena, 53100

Other trials in Italy

About this study

Official title: 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

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.

Being tested
ipragliflozin, Placebo, Metformin
Keywords
Type 2 diabetes, ASP1941, diabetes, metformin
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

  • PlaceboDrug

    oral tablet

  • MetforminDrug

    oral tablet

Study groups in NCT01117584
Study groupRoleWhat they receive
ASP1941 lowest doseExperimentaloral tablet
Receives: Drug: ipragliflozin; Drug: Metformin
ASP1941 low doseExperimentaloral tablet
Receives: Drug: ipragliflozin; Drug: Metformin
ASP1941 high doseExperimentaloral tablet
Receives: Drug: ipragliflozin; Drug: Metformin
ASP1941 highest doseExperimentaloral tablet
Receives: Drug: ipragliflozin; Drug: Metformin
PlaceboPlacebo comparatororal tablet
Receives: Drug: Placebo; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HbA1c at Week 12

    Measured: Baseline, 12 weeks

Secondary outcomes (3)

  1. Change from baseline in fasting plasma glucose (FPG) at Week 12

    Measured: Baseline, 12 weeks

  2. Achievement of target goal (HbA1c <7.0%) at Week 12

    Measured: 12 weeks

  3. Achievement of target goal (HbA1c <6.5%) at Week 12

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2010 (estimated)
  2. Study start6 Apr 2010
  3. Primary completion1 Apr 2011
  4. Study completion1 Apr 2011

Resources

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
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01117584
Sponsor's protocol ID
1941-CL-0005
Other IDs
2009-013881-25, 2009
Acronym
BALANCE
Status last verified
May 2025
First submitted
4 May 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 31606880

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ipragliflozin and Metformin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 44 sites in 6 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 6 inclusion and 21 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 44 sites in Romania, Poland, Hungary, United States, United Kingdom and 1 more country. 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?

Change from baseline in HbA1c at Week 12 (time frame: Baseline, 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 NCT01117584, 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 22 May 2025.

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