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

Astellas

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: ipragliflozin; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135433

1941-CL-0106

Details and patient eligibility

About

This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin 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 metformin in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with metformin alone. The effects of ASP1941 are compared with those of placebo.

Enrollment: 168 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 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
• Estimated GFR < 60ml/min/1.73m2
• 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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168 participants in 2 patient groups, including a placebo group

ASP group

Experimental group

Description:

ASP1941 and metformin

Treatment:

Drug: metformin

Drug: ipragliflozin

Placebo group

Placebo Comparator group

Description:

placebo and metformin

Treatment:

Drug: metformin

Drug: Placebo