A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Sulfonylurea in Type 2 Diabetic Patients

Astellas

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Device: ipragliflozin; Drug: Sulfonylurea

Study type: Interventional

Funder types: Industry

Identifiers

NCT01242215

1941-CL-0109

Details and patient eligibility

About

This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus.

Full description

This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.

Enrollment: 243 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetic patients receiving with sulfonylurea mono-therapy for at least 4 weeks
• HbA1c value between 7.0 and 9.5%
• Body Mass Index (BMI) 20.0 - 45.0 kg/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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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243 participants in 2 patient groups, including a placebo group

ASP group

Experimental group

Description:

ASP1941 and sulfonylurea

Treatment:

Drug: Sulfonylurea

Device: ipragliflozin

Placebo group

Placebo Comparator group

Description:

placebo and sulfonylurea

Treatment:

Drug: Sulfonylurea

Drug: Placebo