Clinical trial NCT02897219: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: SGLT2 inhibitor
ASP1941
type 1 diabetes mellitus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 175
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline and Week 24 (end of treatment period 1)
Secondary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline and up to Week 56
measure: Change from baseline in Fasting plasma glucose
timeFrame: Baseline and up to Week 56
measure: Change from baseline in self-monitored blood glucose level
timeFrame: Baseline and up to Week 56
measure: Change from baseline in leptin
timeFrame: Baseline and up to Week 52
measure: Change from baseline in glycoalbumin
timeFrame: Baseline and up to Week 52
measure: Change from baseline in adiponectin
timeFrame: Baseline and up to Week 52
measure: Change from baseline in glucagon
timeFrame: Baseline and up to Week 52
measure: Change from baseline in number of units of insulin administered concomitantly
timeFrame: Baseline and up to Week 56
measure: Change from baseline in body weight
timeFrame: Baseline and up to Week 56
measure: Change from baseline in waist circumference
timeFrame: Baseline and up to Week 52
measure: Safety assessed by incidence of adverse events
timeFrame: Up to Week 56
measure: Safety assessed by sitting blood pressure
timeFrame: Up to Week 56
measure: Safety assessed by sitting pulse rate
timeFrame: Up to Week 56
measure: Safety assessed by standard 12-lead electrocardiogram
timeFrame: Up to Week 56
measure: Safety assessed by laboratory tests: Hematology
timeFrame: Up to Week 56
measure: Safety assessed by laboratory tests: Biochemistry
timeFrame: Up to Week 56
measure: Safety assessed by laboratory tests: Urinalysis
timeFrame: Up to Week 56
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site JP00005
city: Aichi
country: Japan
facility: Site JP00028
city: Chiba
country: Japan
facility: Site JP00003
city: Chiba
country: Japan
facility: Site JP00013
city: Chiba
country: Japan
facility: Site JP00035
city: Fukuoka
country: Japan
facility: Site JP00022
city: Fukuoka
country: Japan
facility: Site JP00023
city: Fukuoka
country: Japan
facility: Site JP00031
city: Gunma
country: Japan
facility: Site JP00002
city: Gunma
country: Japan
facility: Site JP00011
city: Hiroshima
country: Japan
facility: Site JP00006
city: Hokkaido
country: Japan
facility: Site JP00033
city: Hokkaido
country: Japan
facility: Site JP00034
city: Hyogo
country: Japan
facility: Site JP00021
city: Ibaraki
country: Japan
facility: Site JP00009
city: Ibaraki
country: Japan
facility: Site JP00010
city: Kanagawa
country: Japan
facility: Site JP00004
city: Kanagawa
country: Japan
facility: Site JP00015
city: Kanagawa
country: Japan
facility: Site JP00016
city: Mie
country: Japan
facility: Site JP00019
city: Nagasaki
country: Japan
facility: Site JP00008
city: Nagasaki
country: Japan
facility: Site JP00024
city: Nagasaki
country: Japan
facility: Site JP00025
city: Nagasaki
country: Japan
facility: Site JP00032
city: Niigata
country: Japan
facility: Site JP00026
city: Osaka
country: Japan
facility: Site JP00020
city: Osaka
country: Japan
facility: Site JP00029
city: Osaka
country: Japan
facility: Site JP00036
city: Saitama
country: Japan
facility: Site JP00012
city: Shizuoka
country: Japan
facility: Site JP00017
city: Shizuoka
country: Japan
facility: Site JP00018
city: Tochigi
country: Japan
facility: Site JP00001
city: Tokushima
country: Japan
facility: Site JP00030
city: Tokyo
country: Japan
facility: Site JP00014
city: Toyama
country: Japan
facility: Site JP00027
city: Yamaguchi
country: Japan
facility: Site JP00007
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: