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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: ipragliflozin; Drug: Placebo; Drug: metformin

• Registration Number: NCT01135433
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-05-15
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2011-11-28
• Study Completion: 2011-11-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP group	ipragliflozin	ASP1941 and metformin
Placebo group	Placebo	placebo and metformin
ASP group	metformin	ASP1941 and metformin
Placebo group	metformin	placebo and metformin

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	Baseline and for 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in fasting plasma glucose	Baseline and for 24 weeks
Change from baseline in fasting serum insulin	Baseline and for 24 weeks
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)	for 52 weeks