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

Astellas

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: ipragliflozin; Drug: Pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225081

1941-CL-0107

Details and patient eligibility

About

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

Full description

This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with pioglitazone in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with pioglitazone 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: 152 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetic patients receiving pioglitazone 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
• Heart failure patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 2 patient groups, including a placebo group

ASP group

Experimental group

Description:

ASP1941 and pioglitazone

Treatment:

Drug: Pioglitazone

Drug: ipragliflozin

Placebo group

Placebo Comparator group

Description:

placebo and pioglitazone

Treatment:

Drug: Pioglitazone

Drug: Placebo