A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02897219
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 ASP1941 Insulin Therapy ASP1941 will be administered for 24 weeks under double blind conditions. Part 1 Placebo Insulin Therapy Placebo will be administered for 24 weeks under double blind conditions. Part 2 ASP1941 Insulin Therapy ASP1941 will be administered for 28 weeks under open label conditions. Part 1 ASP1941 ipragliflozin ASP1941 will be administered for 24 weeks under double blind conditions. Part 1 Placebo Placebo Placebo will be administered for 24 weeks under double blind conditions. Part 2 ASP1941 ipragliflozin ASP1941 will be administered for 28 weeks under open label conditions.
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c Baseline and Week 24 (end of treatment period 1)
- Secondary Outcome Measures
Name Time Method Change from baseline in HbA1c Baseline and up to Week 56 Change from baseline in waist circumference Baseline and up to Week 52 Change from baseline in leptin Baseline and up to Week 52 Change from baseline in adiponectin Baseline and up to Week 52 Change from baseline in glucagon Baseline and up to Week 52 Change from baseline in number of units of insulin administered concomitantly Baseline and up to Week 56 Comprehensively assessed by basal insulin daily dose, bolus insulin daily dose and total insulin daily dose.
Change from baseline in Fasting plasma glucose Baseline and up to Week 56 Safety assessed by incidence of adverse events Up to Week 56 Safety assessed by sitting blood pressure Up to Week 56 Safety assessed by sitting pulse rate Up to Week 56 Change from baseline in self-monitored blood glucose level Baseline and up to Week 56 Safety assessed by laboratory tests: Hematology Up to Week 56 Safety assessed by laboratory tests: Urinalysis Up to Week 56 Change from baseline in body weight Baseline and up to Week 56 Safety assessed by standard 12-lead electrocardiogram Up to Week 56 Safety assessed by laboratory tests: Biochemistry Up to Week 56 Change from baseline in glycoalbumin Baseline and up to Week 52
Trial Locations
- Locations (36)
Site JP00005
🇯🇵Aichi, Japan
Site JP00022
🇯🇵Fukuoka, Japan
Site JP00006
🇯🇵Hiroshima, Japan
Site JP00021
🇯🇵Hyogo, Japan
Site JP00004
🇯🇵Kanagawa, Japan
Site JP00015
🇯🇵Kanagawa, Japan
Site JP00020
🇯🇵Osaka, Japan
Site JP00029
🇯🇵Osaka, Japan
Site JP00007
🇯🇵Yamaguchi, Japan
Site JP00013
🇯🇵Chiba, Japan
Site JP00033
🇯🇵Hokkaido, Japan
Site JP00028
🇯🇵Aichi, Japan
Site JP00003
🇯🇵Chiba, Japan
Site JP00035
🇯🇵Chiba, Japan
Site JP00023
🇯🇵Fukuoka, Japan
Site JP00031
🇯🇵Fukuoka, Japan
Site JP00002
🇯🇵Gunma, Japan
Site JP00011
🇯🇵Gunma, Japan
Site JP00034
🇯🇵Hokkaido, Japan
Site JP00009
🇯🇵Ibaraki, Japan
Site JP00010
🇯🇵Ibaraki, Japan
Site JP00016
🇯🇵Kanagawa, Japan
Site JP00019
🇯🇵Mie, Japan
Site JP00008
🇯🇵Nagasaki, Japan
Site JP00024
🇯🇵Nagasaki, Japan
Site JP00025
🇯🇵Nagasaki, Japan
Site JP00026
🇯🇵Niigata, Japan
Site JP00032
🇯🇵Nagasaki, Japan
Site JP00036
🇯🇵Osaka, Japan
Site JP00012
🇯🇵Saitama, Japan
Site JP00017
🇯🇵Shizuoka, Japan
Site JP00018
🇯🇵Shizuoka, Japan
Site JP00001
🇯🇵Tochigi, Japan
Site JP00014
🇯🇵Tokyo, Japan
Site JP00030
🇯🇵Tokushima, Japan
Site JP00027
🇯🇵Toyama, Japan