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Phase III Study of ASP1941 Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 1 Diabetes Mellitus (NCT02897219)

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).
  • Drug: ipragliflozin
    Oral administration once daily
    • ASP1941
  • Drug: Placebo
    Oral administration once daily
    • Other: Insulin Therapy
      Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
      Ages eligible for Study
      20 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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.
      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.

      36 locations

      Japan (36)
      • Site JP00005
        Not specified
        Aichi, Japan
      • Site JP00028
        Not specified
        Aichi, Japan
      • Site JP00003
        Not specified
        Chiba, Japan
      • Site JP00013
        Not specified
        Chiba, Japan
      • Site JP00035
        Not specified
        Chiba, Japan
      • Site JP00022
        Not specified
        Fukuoka, Japan
      • Site JP00023
        Not specified
        Fukuoka, Japan
      • Site JP00031
        Not specified
        Fukuoka, Japan
      • Site JP00002
        Not specified
        Gunma, Japan
      • Site JP00011
        Not specified
        Gunma, Japan
      • Site JP00006
        Not specified
        Hiroshima, Japan
      • Site JP00033
        Not specified
        Hokkaido, Japan
      • Site JP00034
        Not specified
        Hokkaido, Japan
      • Site JP00021
        Not specified
        Hyogo, Japan
      • Site JP00009
        Not specified
        Ibaraki, Japan
      • Site JP00010
        Not specified
        Ibaraki, Japan
      • Site JP00004
        Not specified
        Kanagawa, Japan
      • Site JP00015
        Not specified
        Kanagawa, Japan
      • Site JP00016
        Not specified
        Kanagawa, Japan
      • Site JP00019
        Not specified
        Mie, Japan
      • Site JP00008
        Not specified
        Nagasaki, Japan
      • Site JP00024
        Not specified
        Nagasaki, Japan
      • Site JP00025
        Not specified
        Nagasaki, Japan
      • Site JP00032
        Not specified
        Nagasaki, Japan
      • Site JP00026
        Not specified
        Niigata, Japan
      • Site JP00020
        Not specified
        Osaka, Japan
      • Site JP00029
        Not specified
        Osaka, Japan
      • Site JP00036
        Not specified
        Osaka, Japan
      • Site JP00012
        Not specified
        Saitama, Japan
      • Site JP00017
        Not specified
        Shizuoka, Japan
      • Site JP00018
        Not specified
        Shizuoka, Japan
      • Site JP00001
        Not specified
        Tochigi, Japan
      • Site JP00030
        Not specified
        Tokushima, Japan
      • Site JP00014
        Not specified
        Tokyo, Japan
      • Site JP00027
        Not specified
        Toyama, Japan
      • Site JP00007
        Not specified
        Yamaguchi, Japan
      Status:
      active not recruiting
      Type:
      Interventional
      Phase:
      Start:
      28 August, 2016
      Updated:
      24 September, 2017
      Participants:
      175
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