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Astellas Study ID
1941-CL-2009

A Study to Assess the Efficacy and Safety of ASP1941 in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

Astellas Study ID
NCT02452632
Clinicaltrials.gov ID
NCT02452632
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in combination with metformin and sitagliptin against placebo in combination with metformin and sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with inadequate

glycemic control on metformin and sitagliptin.

Additional Study Details

Phase
3
Product
  • ASP1941
  • Placebo
    • Type
    Interventional
    Masking
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Enrollment number
    143
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    Study documents

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

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    Would you like more information about clinical trial sites that are recruiting participants for A Study to Assess the Efficacy and Safety of ASP1941 in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin? Contact us by filling out your information to the right and we’ll respond to you.

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      Locations

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      Completed
      Site KR00003
      Busan, Busan, Republic of Korea
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      Site KR00016
      Seoul, Seoul, Republic of Korea
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      Completed
      Site KR00008
      Gangwon-do, Gangwon-Do, Republic of Korea
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      Completed
      Site KR00020
      Jeollabuk-do, Jeollabuk-do, Republic of Korea
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      Completed
      Site KR00021
      Kyungsangnam-do, Kyungsangnam-do, Republic of Korea
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      Completed
      Site KR00009
      Seoul, Seoul, Republic of Korea
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      Completed
      Site KR00017
      Seoul, Seoul, Republic of Korea
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      Completed
      Site KR00019
      Dong Gu Gwangju, Dong Gu Gwangju, Republic of Korea
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      Site KR00014
      Incheon, Incheon, Republic of Korea
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      Site KR00011
      Daegu, Daegu, Republic of Korea
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      Completed
      Site KR00004
      Seoul, Seoul, Republic of Korea
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      Completed
      Site KR00002
      Busan, Busan, Republic of Korea
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      Completed
      Site KR00012
      Seoul, Seoul, Republic of Korea
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      Site KR00006
      Seoul, Seoul, Republic of Korea
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      Site KR00018
      Gyeonggi-do, Gyeonggi-do, Republic of Korea
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      Site KR00005
      Seoul, Seoul, Republic of Korea
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      Site KR00022
      Gyeonggi-do, Gyeonggi-do, Republic of Korea
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      Site KR00010
      Seoul, Seoul, Republic of Korea
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      Completed
      Site KR00001
      Seoul, Seoul, Republic of Korea
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      Completed
      Site KR00013
      Seoul, Seoul, Republic of Korea
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      Completed
      Site KR00007
      Daegu, Daegu, Republic of Korea
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      Completed
      Site KR00015
      Suwon, Suwon, Republic of Korea
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      Trial info
      Follow Trial
      Age
      19 - 74 years
      Diamond icon
      Condition
    • Adult Onset Diabetes
      • Gender icon
      Sex
      Female & Male
      Calendar icon
      Trial Dates
      Jun 2015 - Jan 2017
      Additional Study Details
      Inclusion Criteria

        Inclusion Criteria:

      • Subject has been diagnosed with type 2 diabetes mellitus.
      • Subject has an HbA1c value between 7.0% and 10.5 % at visit 1.
      • Subject shows FPG (Fasting Plasma Glucose) value is less than 270mg/dL.
      • Subject shows a BMI of 20.0 to 45.0 kg/m2.
      • Subject is on stable diet and exercise program at least 8 weeks prior to study participation.
      • Postmenopausal female or surgically sterile female or agree not to become pregnant.

        • Exclusion Criteria:

      • Subject has type 1 diabetes mellitus.
      • Subject has proliferative diabetic retinopathy.
      • Subject has a history of clinically significant renal disease(s) such

        • as renovascular occlusive disease, nephrectomy, or renal

        transplant.

      • Subject has significant dysuria caused by a neurogenic bladder or

        • a benign prostatic hypertrophy etc.

      • Subject has a symptomatic urinary tract infection or genital

        • infection.

      • Subject has chronic disease(s) that require the continuous use of

        • systemic corticosteroids or immunosuppressants.

      • Subject has cardiovascular disease or cerebrovascular disease that

        • may affect the administration of ASP1941 or its safety assessment

        in the opinion of the investigator or sub-investigator.

      • Subject has uncontrollable psychiatric disorder(s) with

        • medication.

      • Male subject is not willing to use appropriate contraception during the study.
      • Subject has severe infection, serious trauma, or perioperative

        • subject.

      • Subject has a malignant tumor or has a history of malignant tumor.
      • Subject has severe gastrointestinal disease, or history of operation for serious gastrointestinal disease.
      • Subject has diabetic ketoacidosis.
      • Subject has lactic acidosis or has history of lactic acidosis.
      • Subject has hepatitis or is a carrier of hepatitis B surface antigen

        • (HBsAg), hepatitis C virus (HCV) antibody, or is positive for

        HIV-1 and/or HIV-2.

      • Subject has a history of thyroid dysfunction and acute pancreatitis.
      • Subject is on weight-loss program or weight-loss medication (e.g.
        • rlistat, phentermine/topiramate, lorcaserin) within 12 weeks of

        • study participation.

      • Subject has a history of serious cardiac diseases (NYHA Class III

        • to IV), congestive heart failure, arrhythmia in need of medical

        treatment.

      • Subject has a history of cerebrovascular attack, unstable angina,

        • myocardial infarction, angioplasty, within 52 weeks (364 days) of

        study participation.

      • Subject has uncontrollable severe hypertension, i.e., systolic blood pressure of higher than 180 mmHg or diastolic blood pressure of higher than 110mmHg measured in a sitting position after a 5-minute rest.
      • Subject has following AST or ALT value:
        • AST: Male > 100 U/L, Female > 80 U/L
        • ALT: Male > 102.5 U/L, Female > 82.5 U/L
      • Subject has following serum creatinine value:
        • Creatinine: Male > 1.3 mg/dL, Female > 1.2 mg/dL
      • Subject has estimated GFR values, of < 60 mL/min/1.73m2.

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