A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients

Astellas

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: ipragliflozin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01672762

1941-CL-0122

Details and patient eligibility

About

This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.

Full description

Subjects will undergo the 6-week screening period before entering the 24-week treatment period and will receive ASP1941 before breakfast during the treatment period. All subjects will be followed for 4 weeks after study treatment is discontinued.

Enrollment

174 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes mellitus patients
Subject is only on a diet and exercise program or has received a single antihyperglycemic agent or two antihyperglycemic agents (excluding insulin) with low dose (≤50% of the maximum dose of each recommended dosage)
Subject has a HbA1c value (JDS value) between 6.5% and 9.5% and the difference of HbA1c values (JDS value) within ± 1.0%
BMI 20.0 - 45.0 kg/m2

Exclusion criteria

Type 1 Diabetes Mellitus
Subject has received insulin within 12 weeks (84 days) before the study
Subject has proliferative diabetic retinopathy
Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
Subject with obvious dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy
Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 12 weeks (84 days). Subject has heart disease, cerebral vascular disease which, in the opinion of the principal investigator or the sub-investigator, may interfere with treatment or evaluation of safety of this study.
Female subject who is currently pregnant or lactating, or who is possibly pregnant
Male and pre-menopausal Female subject who cannot use an appropriate contraception during the study
Subject has a history of treatment with ASP1941
Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies
Subject has a serum creatinine value higher than upper limit of normal range
Subject has a urinary microalbumin/ urinary creatinine ratio > 300 mg/g in urinalysis
Subject has uncontrolled severe hypertension (subject whose systolic blood pressure is > 170 mmHg or diastolic blood pressure of > 95 mmHg measured in a sitting position after 5 minutes of rest
Subject who is judged inappropriate for enrollment into the study by the principal investigator or the sub-investigator