Back to resultsA Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ipragliflozin
Placebo
Insulin Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring SGLT2 inhibitor, ASP1941, type 1 diabetes mellitus
Eligibility Criteria
Inclusion Criteria:
- The subject has been diagnosed with type 1 diabetes mellitus
- The subject has been receiving insulin therapy for the treatment of diabetes mellitus.
- The subject has not switched from an insulin product to another insulin product or switched between continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI).
- The subject has an HbA1c value between 7.5% and 11.0% and the difference of HbA1c value is within ± 2.0%.
- The subject has a fasting blood C-peptide level < 0.6 ng/mL.
- The subject has a body mass index (BMI) between 20.0 kg/m2 and 35.0 kg/m2.
Exclusion Criteria:
- The subject has type 2 diabetes mellitus.
- The subject has participated in a clinical study or post marketing study of another drug or medical equipment within 12 weeks (84 days) before providing written informed consent, or is currently participating in such a study.
- The subject has received treatment with ASP1941 (ipragliflozin) or participated in a clinical study of ASP1941 (excluding subjects who discontinued before the investigational period).
- The subject participated in this study previously.
- The subject has received a hypoglycemic agent other than insulin or an α-glucosidase inhibitor.
- The subject has proliferative retinopathy (except for those who have undergone photocoagulation etc. and whose symptoms are stable).
- The subject has experienced severe hypoglycemia.
- The subject has experienced diabetic ketoacidosis.
- The subject has chronic disease that requires the continuous use of corticosteroids, immunosuppressants, etc.
- The subject has symptomatic urinary tract infection or symptomatic genital infection.
- The subject has a history of recurrent urinary tract infection or recurrent genital infection.
- The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or another serious heart disease.
- The subject has a concomitant malignant tumor or a history of malignant tumor
- The subject has a history of an allergy to ASP1941 (ipragliflozin) and/or similar drugs (drugs possessing SGLT2 inhibitory action).
- The subject has psychiatric disorder that is inappropriate for participation in the study.
- The subject has drug addiction or alcohol abuse.
- The subject has severe infection or serious trauma, or is perioperative.
- The subject has a history of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.
- The subject has any symptoms of dysuria, anuria, oliguria, or urinary retention.
- The subject has severe renal impairment or end-stage renal failure requiring dialysis.
- The subject has an Aspartate Aminotransferase and/or Alanine Aminotransferase value that exceeds 2 times, or a total bilirubin value that exceeds 1.5 times the upper limit of the reference range.
- The subject has uncontrolled severe hypertension.
- The subject has serious gastrointestinal disease or a history of operation for serious gastrointestinal disease.
Sites / Locations
- Site JP00005
- Site JP00028
- Site JP00003
- Site JP00013
- Site JP00035
- Site JP00022
- Site JP00023
- Site JP00031
- Site JP00002
- Site JP00011
- Site JP00006
- Site JP00033
- Site JP00034
- Site JP00021
- Site JP00009
- Site JP00010
- Site JP00004
- Site JP00015
- Site JP00016
- Site JP00019
- Site JP00008
- Site JP00024
- Site JP00025
- Site JP00032
- Site JP00026
- Site JP00020
- Site JP00029
- Site JP00036
- Site JP00012
- Site JP00017
- Site JP00018
- Site JP00001
- Site JP00030
- Site JP00014
- Site JP00027
- Site JP00007
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Part 1 ASP1941
Part 1 Placebo
Part 2 ASP1941
Arm Description
ASP1941 will be administered for 24 weeks under double blind conditions.
Placebo will be administered for 24 weeks under double blind conditions.
ASP1941 will be administered for 28 weeks under open label conditions.
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c
Secondary Outcome Measures
Change from baseline in HbA1c
Change from baseline in Fasting plasma glucose
Change from baseline in self-monitored blood glucose level
Change from baseline in leptin
Change from baseline in glycoalbumin
Change from baseline in adiponectin
Change from baseline in glucagon
Change from baseline in number of units of insulin administered concomitantly
Comprehensively assessed by basal insulin daily dose, bolus insulin daily dose and total insulin daily dose.
Change from baseline in body weight
Change from baseline in waist circumference
Safety assessed by incidence of adverse events
Safety assessed by sitting blood pressure
Safety assessed by sitting pulse rate
Safety assessed by standard 12-lead electrocardiogram
Safety assessed by laboratory tests: Hematology
Safety assessed by laboratory tests: Biochemistry
Safety assessed by laboratory tests: Urinalysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02897219
Brief Title
A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus
Official Title
Phase III Study of ASP1941 Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
July 22, 2017 (Actual)
Study Completion Date
March 15, 2018 (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 objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks. This study will also assess the safety/efficacy of long-term treatment (52 weeks).
Detailed Description
This study consists of two parts. In Part 1, ASP1941 or placebo will be administered orally in a blind manner. In Part 2, the long-term safety and efficacy of ASP1941 will be evaluated in patients who have participated in the study and completed the Part 1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
SGLT2 inhibitor, ASP1941, type 1 diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1 ASP1941
Arm Type
Experimental
Arm Description
ASP1941 will be administered for 24 weeks under double blind conditions.
Arm Title
Part 1 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered for 24 weeks under double blind conditions.
Arm Title
Part 2 ASP1941
Arm Type
Experimental
Arm Description
ASP1941 will be administered for 28 weeks under open label conditions.
Intervention Type
Drug
Intervention Name(s)
ipragliflozin
Other Intervention Name(s)
ASP1941
Intervention Description
Oral administration once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration once daily
Intervention Type
Other
Intervention Name(s)
Insulin Therapy
Intervention Description
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
Baseline and Week 24 (end of treatment period 1)
Secondary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
Baseline and up to Week 56
Title
Change from baseline in Fasting plasma glucose
Time Frame
Baseline and up to Week 56
Title
Change from baseline in self-monitored blood glucose level
Time Frame
Baseline and up to Week 56
Title
Change from baseline in leptin
Time Frame
Baseline and up to Week 52
Title
Change from baseline in glycoalbumin
Time Frame
Baseline and up to Week 52
Title
Change from baseline in adiponectin
Time Frame
Baseline and up to Week 52
Title
Change from baseline in glucagon
Time Frame
Baseline and up to Week 52
Title
Change from baseline in number of units of insulin administered concomitantly
Description
Comprehensively assessed by basal insulin daily dose, bolus insulin daily dose and total insulin daily dose.
Time Frame
Baseline and up to Week 56
Title
Change from baseline in body weight
Time Frame
Baseline and up to Week 56
Title
Change from baseline in waist circumference
Time Frame
Baseline and up to Week 52
Title
Safety assessed by incidence of adverse events
Time Frame
Up to Week 56
Title
Safety assessed by sitting blood pressure
Time Frame
Up to Week 56
Title
Safety assessed by sitting pulse rate
Time Frame
Up to Week 56
Title
Safety assessed by standard 12-lead electrocardiogram
Time Frame
Up to Week 56
Title
Safety assessed by laboratory tests: Hematology
Time Frame
Up to Week 56
Title
Safety assessed by laboratory tests: Biochemistry
Time Frame
Up to Week 56
Title
Safety assessed by laboratory tests: Urinalysis
Time Frame
Up to Week 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject has been diagnosed with type 1 diabetes mellitus
The subject has been receiving insulin therapy for the treatment of diabetes mellitus.
The subject has not switched from an insulin product to another insulin product or switched between continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI).
The subject has an HbA1c value between 7.5% and 11.0% and the difference of HbA1c value is within ± 2.0%.
The subject has a fasting blood C-peptide level < 0.6 ng/mL.
The subject has a body mass index (BMI) between 20.0 kg/m2 and 35.0 kg/m2.
Exclusion Criteria:
The subject has type 2 diabetes mellitus.
The subject has participated in a clinical study or post marketing study of another drug or medical equipment within 12 weeks (84 days) before providing written informed consent, or is currently participating in such a study.
The subject has received treatment with ASP1941 (ipragliflozin) or participated in a clinical study of ASP1941 (excluding subjects who discontinued before the investigational period).
The subject participated in this study previously.
The subject has received a hypoglycemic agent other than insulin or an α-glucosidase inhibitor.
The subject has proliferative retinopathy (except for those who have undergone photocoagulation etc. and whose symptoms are stable).
The subject has experienced severe hypoglycemia.
The subject has experienced diabetic ketoacidosis.
The subject has chronic disease that requires the continuous use of corticosteroids, immunosuppressants, etc.
The subject has symptomatic urinary tract infection or symptomatic genital infection.
The subject has a history of recurrent urinary tract infection or recurrent genital infection.
The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or another serious heart disease.
The subject has a concomitant malignant tumor or a history of malignant tumor
The subject has a history of an allergy to ASP1941 (ipragliflozin) and/or similar drugs (drugs possessing SGLT2 inhibitory action).
The subject has psychiatric disorder that is inappropriate for participation in the study.
The subject has drug addiction or alcohol abuse.
The subject has severe infection or serious trauma, or is perioperative.
The subject has a history of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.
The subject has any symptoms of dysuria, anuria, oliguria, or urinary retention.
The subject has severe renal impairment or end-stage renal failure requiring dialysis.
The subject has an Aspartate Aminotransferase and/or Alanine Aminotransferase value that exceeds 2 times, or a total bilirubin value that exceeds 1.5 times the upper limit of the reference range.
The subject has uncontrolled severe hypertension.
The subject has serious gastrointestinal disease or a history of operation for serious gastrointestinal disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site JP00005
City
Aichi
Country
Japan
Facility Name
Site JP00028
City
Aichi
Country
Japan
Facility Name
Site JP00003
City
Chiba
Country
Japan
Facility Name
Site JP00013
City
Chiba
Country
Japan
Facility Name
Site JP00035
City
Chiba
Country
Japan
Facility Name
Site JP00022
City
Fukuoka
Country
Japan
Facility Name
Site JP00023
City
Fukuoka
Country
Japan
Facility Name
Site JP00031
City
Fukuoka
Country
Japan
Facility Name
Site JP00002
City
Gunma
Country
Japan
Facility Name
Site JP00011
City
Gunma
Country
Japan
Facility Name
Site JP00006
City
Hiroshima
Country
Japan
Facility Name
Site JP00033
City
Hokkaido
Country
Japan
Facility Name
Site JP00034
City
Hokkaido
Country
Japan
Facility Name
Site JP00021
City
Hyogo
Country
Japan
Facility Name
Site JP00009
City
Ibaraki
Country
Japan
Facility Name
Site JP00010
City
Ibaraki
Country
Japan
Facility Name
Site JP00004
City
Kanagawa
Country
Japan
Facility Name
Site JP00015
City
Kanagawa
Country
Japan
Facility Name
Site JP00016
City
Kanagawa
Country
Japan
Facility Name
Site JP00019
City
Mie
Country
Japan
Facility Name
Site JP00008
City
Nagasaki
Country
Japan
Facility Name
Site JP00024
City
Nagasaki
Country
Japan
Facility Name
Site JP00025
City
Nagasaki
Country
Japan
Facility Name
Site JP00032
City
Nagasaki
Country
Japan
Facility Name
Site JP00026
City
Niigata
Country
Japan
Facility Name
Site JP00020
City
Osaka
Country
Japan
Facility Name
Site JP00029
City
Osaka
Country
Japan
Facility Name
Site JP00036
City
Osaka
Country
Japan
Facility Name
Site JP00012
City
Saitama
Country
Japan
Facility Name
Site JP00017
City
Shizuoka
Country
Japan
Facility Name
Site JP00018
City
Shizuoka
Country
Japan
Facility Name
Site JP00001
City
Tochigi
Country
Japan
Facility Name
Site JP00030
City
Tokushima
Country
Japan
Facility Name
Site JP00014
City
Tokyo
Country
Japan
Facility Name
Site JP00027
City
Toyama
Country
Japan
Facility Name
Site JP00007
City
Yamaguchi
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=308
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus
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