Type 2 Diabetes Mellitus
Conditions
Keywords
glucose excretion, ipragliflozin, hypoglycemic agents, serum Insulin, diabetes mellitus, blood glucose
Brief summary
This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.
Detailed 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.
Interventions
DRUGipragliflozin
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting serum insulin | Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
| Change in waist circumference | Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
| Change in fasting plasma glucose | Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
| Change in urine glucose | Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
| Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs | 24 weeks |
| Change in body weight | Before and at 4-, 8-, 12-, 16-, 20- and 24-week |
Countries
Japan
Outcome results
None listed