Clinical trial NCT01505426: A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
Official title: A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type II Diabetes Mellitus
Keywords: ASP1941
ipragliflozin
urine glucose
metformin
plasma glucose
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-01-06
Enrollment: 171
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: To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.


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 8 weeks before the study
* On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
* BMI of 20.0 to 45.0 kg/m2
* A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose

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
* 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 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: Jeonju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.