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

NCT ID: NCT01672762

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-25
• Study Completion Date: 2013-04-13

Brief Summary

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

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASP1941 group

oral

Group Type: EXPERIMENTAL

ipragliflozin

Intervention Type: DRUG

oral

Interventions

ipragliflozin

oral

Intervention Type: DRUG

Other Intervention Names

ASP1941

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Chūbu, , Japan

Hokkaido, , Japan

Kansai, , Japan

Kantou, , Japan

Kyushu, , Japan

Shikoku, , Japan

Tōhoku, , Japan

Countries

Japan

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=107

Link to results on Astellas Clinical Study Results website

Other Identifiers

1941-CL-0122

Identifier Type: -

Identifier Source: org_study_id