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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Phase III Study of ASP1941 -A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672762
• Other study ID #: 1941-CL-0122
• Status: Completed
• Phase: Phase 3
• Start date: May 25, 2012
• Est. completion date: April 13, 2013

Study information

• Verified date: June 2022
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 13, 2013
• Est. primary completion date: April 13, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ipragliflozin
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Secondary	Change in fasting plasma glucose		Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Secondary	Change in fasting serum insulin		Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Secondary	Change in waist circumference		Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Secondary	Change in body weight		Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Secondary	Change in urine glucose		Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Secondary	Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs		24 weeks

External Links

•   Link to results on Astellas Clinical Study Results website