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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-15

Study Completion Date

2012-04-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ASP group

ASP1941 and pioglitazone

Group Type EXPERIMENTAL

ipragliflozin

Intervention Type DRUG

oral

Pioglitazone

Intervention Type DRUG

oral

Placebo group

placebo and pioglitazone

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Pioglitazone

Intervention Type DRUG

oral

Interventions

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ipragliflozin

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Pioglitazone

oral

Intervention Type DRUG

Other Intervention Names

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ASP1941 Actos

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No