This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: August 22, 2012
Last updated: January 19, 2016
Last verified: January 2016
This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: ASP1941 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of ASP1941 - A Long-term Administration Study in Subjects With Type 2 Diabetes Mellitus (T2DM)

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ]
  • Change in fasting serum insulin [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ]
  • Change in waist circumference [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ]
  • Change in body weight [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ]
  • Change in urine glucose [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ]
  • Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs [ Time Frame: 24 weeks ]

Enrollment: 174
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 group
Drug: ASP1941
Other Name: ipragliflozin

Detailed Description:
Subjects will undergo the 6-week screening period before entering the 24-week treatment period and will receive ASP1941 before breakfast during the treatment period. All subjects will be followed for 4 weeks after study treatment is discontinued.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes mellitus patients
  • Subject is only on a diet and exercise program or has received a single antihyperglycemic agent or two antihyperglycemic agents (excluding insulin) with low dose (≤50% of the maximum dose of each recommended dosage)
  • Subject has a HbA1c value (JDS value) between 6.5% and 9.5% and the difference of HbA1c values (JDS value) within ± 1.0%
  • BMI 20.0 - 45.0 kg/m2

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Subject has received insulin within 12 weeks (84 days) before the study
  • Subject has proliferative diabetic retinopathy
  • Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
  • Subject with obvious dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy
  • Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 12 weeks (84 days). Subject has heart disease, cerebral vascular disease which, in the opinion of the principal investigator or the sub-investigator, may interfere with treatment or evaluation of safety of this study.
  • Female subject who is currently pregnant or lactating, or who is possibly pregnant
  • Male and pre-menopausal Female subject who cannot use an appropriate contraception during the study
  • Subject has a history of treatment with ASP1941
  • Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies
  • Subject has a serum creatinine value higher than upper limit of normal range
  • Subject has a urinary microalbumin/ urinary creatinine ratio > 300 mg/g in urinalysis
  • Subject has uncontrolled severe hypertension (subject whose systolic blood pressure is > 170 mmHg or diastolic blood pressure of > 95 mmHg measured in a sitting position after 5 minutes of rest
  • Subject who is judged inappropriate for enrollment into the study by the principal investigator or the sub-investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01672762

Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Medical Director Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01672762     History of Changes
Other Study ID Numbers: 1941-CL-0122
Study First Received: August 22, 2012
Last Updated: January 19, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
diabetes mellitus
serum Insulin
blood glucose
glucose excretion
hypoglycemic agents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 21, 2017