A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients

Astellas Pharma Inc106 enrolled

Overview

This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.

This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on a DPP-4 inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Type 2 Diabetes Mellitus

Interventions

ipragliflozinDRUG

oral

DPP-4 inhibitorDRUG

oral

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetic patients receiving with DPP-4 inhibitor mono-therapy for at least 4 weeks * HbA1c value between 6.5 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

Locations (6)

Unnamed facility

Chūbu, Japan

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Unnamed facility

Kyushu, Japan

Outcomes

Primary Outcomes

Change from baseline in HbA1c

Time frame: baseline and 52 weeks

Secondary Outcomes

Change from baseline in fasting plasma glucose

Time frame: baseline and 52 weeks

Change from baseline in fasting serum insulin

Time frame: baseline and 52 weeks

Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)

Time frame: for 52 weeks

Data from ClinicalTrials.gov

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