A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Long-term 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: NCT01054092
• Other study ID #: 1941-CL-0121
• Status: Completed
• Phase: Phase 3
• Start date: January 14, 2010
• Est. completion date: July 22, 2011

Study information

• Verified date: May 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.

Description:

Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 22, 2011
• Est. primary completion date: July 22, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetic patients for at least 12 weeks

• HbA1c value between 6.5 and 9.5%

• Body Mass Index ( BMI )20.0 - 45.0kg/m2

Exclusion Criteria:

• Type 1 diabetes mellitus patients

• Serum creatinine > upper limit of normal

• Proteinuria (albumin/creatinine ratio > 300mg/g)

• Dysuria and/or urinary tract infection, genital infection

• Significant renal, hepatic or cardiovascular diseases

• Severe gastrointestinal diseases

• Proliferative diabetic retinopathy

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	HbA1c		For 52 weeks
Secondary	Fasting plasma glucose		For 52 weeks
Secondary	Fasting serum insulin		For 52 weeks
Secondary	Plasma levels of ASP1941 for population PK analysis		For 52 weeks
Secondary	Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs		For 52 weeks

External Links

•   Link to results on Astellas Clinical Study Results website