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: April 23, 2013
Last verified: April 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
oral
Drug: ASP1941
oral
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672762

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01672762     History of Changes
Other Study ID Numbers: 1941-CL-0122
Study First Received: August 22, 2012
Last Updated: April 23, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014