Clinical trial NCT01514838: A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
Official title: A Phase III, Double-Blind, Randomized, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type II Diabetes Mellitus
Keywords: urine glucose
ipragliflozin
plasma glucose
ASP1941
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.

Detailed description: This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the ASP1941 or the acarbose group. Subjects will take the study drug under the double-blind condition in the treatment period. After completion of the study drug administration, a follow-up period will be provided.

Eligibility criteria: Inclusion Criteria:

* diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
* stable diet and exercise program for at least 6 weeks before the study
* for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy
* BMI of 20.0 to 45.0 kg/m2
* for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
* for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period

Exclusion Criteria:

* type 1 diabetes mellitus
* proliferative diabetic retinopathy
* receiving insulin within 12 weeks prior to the study
* history of clinically significant renal disease(s)
* significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
* urinary tract infection or genital infection
* continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
* history of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
* severe infection, serious trauma, or perioperative subject
* known or suspected hypersensitivity to ASP1941, acarbose or other alpha-GI
* history of treatment with ASP1941
* participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
* serum creatinine value exceeding the upper limit of normal range
* urinary microalbumin/urinary creatinine ratio \>300 mg/g

Primary outcomes:
measure: Change in HbA1c from baseline to end of treatment
timeFrame: Baseline and up to 24 weeks
Secondary outcomes:
measure: Change in fasting plasma glucose level
timeFrame: Baseline and up to 24 weeks
measure: Change in fasting serum insulin level
timeFrame: Baseline and up to 24 weeks
measure: Change in body weight
timeFrame: Baseline and up to 24 weeks
measure: Change in body waist circumference
timeFrame: Baseline and up to 24 weeks
measure: Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG
timeFrame: For 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seongnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
city: Changha
country: Taiwan
city: Chiayi
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: