A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
Primary Purpose
Type II Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ASP1941
metformin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring ASP1941, ipragliflozin, urine glucose, metformin, plasma glucose
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ASP1941 group
placebo group
Arm Description
ASP1941 + metformin
placebo + metformin
Outcomes
Primary Outcome Measures
Change in HbA1c from baseline to end of treatment
Secondary Outcome Measures
Change in fasting plasma glucose level
Change in fasting serum insulin level
Change in body weight
Change in waist circumference
Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01505426
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 28, 2011 (Actual)
Primary Completion Date
January 14, 2013 (Actual)
Study Completion Date
January 14, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
ASP1941, ipragliflozin, urine glucose, metformin, plasma glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP1941 group
Arm Type
Experimental
Arm Description
ASP1941 + metformin
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo + metformin
Intervention Type
Drug
Intervention Name(s)
ASP1941
Other Intervention Name(s)
ipragliflozin
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
oral, concomitant use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline to end of treatment
Time Frame
Baseline and up to 24 weeks
Secondary Outcome Measure Information:
Title
Change in fasting plasma glucose level
Time Frame
Baseline and up to 24 weeks
Title
Change in fasting serum insulin level
Time Frame
Baseline and up to 24 weeks
Title
Change in body weight
Time Frame
Baseline and up to 24 weeks
Title
Change in waist circumference
Time Frame
Baseline and up to 24 weeks
Title
Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG
Time Frame
For 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Citations:
PubMed Identifier
31606880
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=109
Description
Link to results on Astellas Clinical Study Results Web site
Learn more about this trial
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
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