A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients

Overview[ - collapse ][ - ]

Purpose To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.
ConditionType II Diabetes Mellitus
InterventionDrug: ASP1941
Drug: metformin
Drug: Placebo
PhasePhase 3
SponsorAstellas Pharma Inc
Responsible PartyAstellas Pharma Inc
ClinicalTrials.gov IdentifierNCT01505426
First ReceivedJanuary 4, 2012
Last UpdatedJanuary 16, 2013
Last verifiedJanuary 2013

Tracking Information[ + expand ][ + ]

First Received DateJanuary 4, 2012
Last Updated DateJanuary 16, 2013
Start DateNovember 2011
Estimated Primary Completion DateJanuary 2013
Current Primary Outcome MeasuresChange in HbA1c from baseline to end of treatment [Time Frame: Baseline and up to 24 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change in fasting plasma glucose level [Time Frame: Baseline and up to 24 weeks] [Designated as safety issue: No]
  • Change in fasting serum insulin level [Time Frame: Baseline and up to 24 weeks] [Designated as safety issue: No]
  • Change in body weight [Time Frame: Baseline and up to 24 weeks] [Designated as safety issue: No]
  • Change in waist circumference [Time Frame: Baseline and up to 24 weeks] [Designated as safety issue: No]
  • Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG [Time Frame: For 24 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
Official TitleA 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
Brief Summary
To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian
subjects with type 2 diabetes mellitus.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType II Diabetes Mellitus
InterventionDrug: ASP1941
oral
Other Names:
ipragliflozinDrug: metformin
oral, concomitant use
Drug: Placebo
oral
Study Arm (s)
  • Experimental: ASP1941 group
    ASP1941 + metformin
  • Placebo Comparator: placebo group
    placebo + metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment171
Estimated Completion DateJanuary 2013
Estimated Primary Completion DateJanuary 2013
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
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesKorea, Republic of, Taiwan

Administrative Information[ + expand ][ + ]

NCT Number NCT01505426
Other Study ID Numbers1941-CL-2004
Has Data Monitoring CommitteeNo
Information Provided ByAstellas Pharma Inc
Study SponsorAstellas Pharma Inc
CollaboratorsNot Provided
Investigators Study Chair: Use Central Contact Astellas Pharma Inc
Verification DateJanuary 2013

Locations[ + expand ][ + ]

Korea, Republic of
Busan, Korea, Republic of
Korea, Republic of
Daegu, Korea, Republic of
Korea, Republic of
Daejeon, Korea, Republic of
Korea, Republic of
Gwangju, Korea, Republic of
Korea, Republic of
Incheon, Korea, Republic of
Korea, Republic of
Jeonju, Korea, Republic of
Korea, Republic of
Seoul, Korea, Republic of
Korea, Republic of
Wonju, Korea, Republic of
Taiwan
Kaohsiung, Taiwan
Taiwan
Taichung, Taiwan
Taiwan
Tainan, Taiwan
Taiwan
Taipei, Taiwan