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Astellas Study ID
1941-CL-6002

A Study of ASP1941 in Combination with Insulin in Patients with Type 1 Diabetes Mellitus

Astellas Study ID
NCT02897219
Clinicaltrials.gov ID
NCT02897219
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study 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).

Additional Study Details

Phase
3
Product
  • ipragliflozin
  • Placebo
    • Type
    Interventional
    Masking
    Double (Participant, Investigator)
    Enrollment number
    175
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Download Document(s)
    Plain Language Summary
    Available Language(s): Japanese
    Download Document(s)

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    Would you like more information about clinical trial sites that are recruiting participants for A Study of ASP1941 in Combination with Insulin in Patients with Type 1 Diabetes Mellitus? Contact us by filling out your information to the right and we’ll respond to you.

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    • Taiwan, Province of China
    • Thailand
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    • Ukraine
    • United Kingdom
    • United States
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      Locations

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      Site JP00024
      Nagasaki, Nagasaki, Japan
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      Site JP00016
      Kanagawa, Kanagawa, Japan
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      Site JP00034
      Hokkaido, Hokkaido, Japan
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      Completed
      Site JP00023
      Fukuoka, Fukuoka, Japan
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      Completed
      Site JP00019
      Mie, Mie, Japan
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      Completed
      Site JP00001
      Tochigi, Tochigi, Japan
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      Completed
      Site JP00015
      Kanagawa, Kanagawa, Japan
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      Site JP00030
      Tokushima, Tokushima, Japan
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      Completed
      Site JP00026
      Niigata, Niigata, Japan
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      Site JP00011
      Gunma, Gunma, Japan
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      Site JP00031
      Fukuoka, Fukuoka, Japan
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      Site JP00010
      Ibaraki, Ibaraki, Japan
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      Site JP00003
      Chiba, Chiba, Japan
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      Site JP00014
      Tokyo, Tokyo, Japan
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      Site JP00008
      Nagasaki, Nagasaki, Japan
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      Site JP00029
      Osaka, Osaka, Japan
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      Site JP00017
      Shizuoka, Shizuoka, Japan
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      Site JP00035
      Chiba, Chiba, Japan
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      Site JP00007
      Yamaguchi, Yamaguchi, Japan
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      Site JP00018
      Shizuoka, Shizuoka, Japan
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      Site JP00032
      Nagasaki, Nagasaki, Japan
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      Site JP00006
      Hiroshima, Hiroshima, Japan
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      Site JP00022
      Fukuoka, Fukuoka, Japan
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      Site JP00033
      Hokkaido, Hokkaido, Japan
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      Site JP00027
      Toyama, Toyama, Japan
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      Site JP00009
      Ibaraki, Ibaraki, Japan
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      Completed
      Site JP00021
      Hyogo, Hyogo, Japan
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      Completed
      Site JP00028
      Aichi, Aichi, Japan
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      Completed
      Site JP00020
      Osaka, Osaka, Japan
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      Site JP00036
      Osaka, Osaka, Japan
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      Site JP00025
      Nagasaki, Nagasaki, Japan
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      Site JP00012
      Saitama, Saitama, Japan
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      Completed
      Site JP00004
      Kanagawa, Kanagawa, Japan
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      Completed
      Site JP00005
      Aichi, Aichi, Japan
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      Completed
      Site JP00013
      Chiba, Chiba, Japan
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      Completed
      Site JP00002
      Gunma, Gunma, Japan
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      Trial info
      Follow Trial
      Age
      20+ years
      Diamond icon
      Condition
    • Juvenile Diabetes
      • Gender icon
      Sex
      Female & Male
      Calendar icon
      Trial Dates
      Aug 2016 - Jul 2017
      Additional Study Details
      Inclusion 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.

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