Back to resultsA Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
Primary Purpose
Type II Diabetes Mellitus
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ASP1941
acarbose
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring urine glucose, ipragliflozin, plasma glucose, ASP1941
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1941 group
acarbose group
Arm Description
Once daily over a 24-week treatment period
Once daily over a 24-week treatment period
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 body waist circumference
Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG
Full Information
NCT ID
NCT01514838
First Posted
January 18, 2012
Last Updated
December 13, 2018
Sponsor
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT01514838
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Discontinued due to company's strategic reason
Study Start Date
April 23, 2012 (Actual)
Primary Completion Date
October 19, 2012 (Actual)
Study Completion Date
October 19, 2012 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
urine glucose, ipragliflozin, plasma glucose, ASP1941
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1941 group
Arm Type
Experimental
Arm Description
Once daily over a 24-week treatment period
Arm Title
acarbose group
Arm Type
Active Comparator
Arm Description
Once daily over a 24-week treatment period
Intervention Type
Drug
Intervention Name(s)
ASP1941
Other Intervention Name(s)
ipragliflozin
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
acarbose
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral, used only during placebo run-in period
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 body 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 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
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
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
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."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=108
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
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