A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients

Astellas

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: placebo; Drug: ipragliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057628

1941-CL-0105

Details and patient eligibility

About

This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.

Enrollment: 130 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 7.0 and 10.0%
• Body Mass Index (BMI) 20.0 - 45.0 kg/m2
• Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

ASP1941 group

Experimental group

Description:

oral

Treatment:

Drug: ipragliflozin

placebo group

Placebo Comparator group

Description:

oral

Treatment:

Drug: placebo