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

Astellas

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: ipragliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01054092

1941-CL-0121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

before meal group

Experimental group

Description:

ASP1941 will be administered before meal

Treatment:

Drug: ipragliflozin

after meal group

Experimental group

Description:

ASP1941 will be administered after meal

Treatment:

Drug: ipragliflozin