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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01672762
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ASP1941 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
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)
Study Start Date : June 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ASP1941 group
Drug: ASP1941
Other Name: ipragliflozin

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01672762     History of Changes
Other Study ID Numbers: 1941-CL-0122
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 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