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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01672762
First received: August 22, 2012
Last updated: October 16, 2014
Last verified: October 2014

August 22, 2012
October 16, 2014
June 2012
April 2013   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01672762 on ClinicalTrials.gov Archive Site
  • Change in fasting plasma glucose [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ] [ Designated as safety issue: No ]
  • Change in fasting serum insulin [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ] [ Designated as safety issue: No ]
  • Change in urine glucose [ Time Frame: Before and at 4-, 8-, 12-, 16-, 20- and 24-week ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients
Phase 3 Study of ASP1941 - A Long-term Administration Study in Subjects With Type 2 Diabetes Mellitus (T2DM)

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

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: ASP1941
oral
Other Name: ipragliflozin
Experimental: ASP1941 group
oral
Intervention: Drug: ASP1941
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01672762
1941-CL-0122
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Inc
Astellas Pharma Inc
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP