a study to evaluate the effect of asp1941 in combination with metformin in adult patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

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.


Eligibility 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

Keywords: type 2 diabetes asp1941 diabetes metformin