To assess the efficacy and safety of ASP1941 in combination with Metformin in subjects with Type 2 Diabetes Mellitus

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000365

Enrollment

Registered

2012-02-20

Start date

2011-11-28

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
HbA1c	—

Secondary

Measure	Time frame
fasting plasma glucose level ,fasting serum insulin level ,body weight ,waist circumference ;Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG	—

Countries

Korea, Republic of

Contacts

Public ContactBongsoo Cha

Yonsei University Health System, Severance Hospital

Outcome results