Clinical trial NCT01672762: A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients
Official title: Phase III Study of ASP1941 -A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: glucose excretion
ipragliflozin
hypoglycemic agents
serum Insulin
diabetes mellitus
blood glucose
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-08-27
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Secondary outcomes:
measure: Change in fasting plasma glucose
timeFrame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Change in fasting serum insulin
timeFrame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Change in waist circumference
timeFrame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Change in body weight
timeFrame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Change in urine glucose
timeFrame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week
measure: Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: