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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01117584
First received: May 4, 2010
Last updated: April 29, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: ASP1941
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IIb, 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 Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in HbA1c at Week 12 [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose (FPG) at Week 12 [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Achievement of target goal (HbA1c <7.0%) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Achievement of target goal (HbA1c <6.5%) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 343
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 lowest dose Drug: ASP1941
oral tablet
Experimental: ASP1941 low dose Drug: ASP1941
oral tablet
Experimental: ASP1941 high dose Drug: ASP1941
oral tablet
Experimental: ASP1941 highest dose Drug: ASP1941
oral tablet
Placebo Comparator: Placebo Drug: Placebo
oral tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117584

  Show 45 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Ude Central Contact Astellas Pharma Europe BV
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01117584     History of Changes
Other Study ID Numbers: 1941-CL-0005, 2009-013881-25
Study First Received: May 4, 2010
Last Updated: April 29, 2012
Health Authority: Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Type 2 diabetes
diabetes
ASP1941
metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013