A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Sulfonylurea 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

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-17

Study Completion Date

2012-04-25

Brief Summary

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

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Detailed Description

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This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea 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 sulfonylurea

Group Type EXPERIMENTAL

ipragliflozin

Intervention Type DEVICE

oral

Sulfonylurea

Intervention Type DRUG

oral

Placebo group

placebo and sulfonylurea

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Sulfonylurea

Intervention Type DRUG

oral

Interventions

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ipragliflozin

oral

Intervention Type DEVICE

Placebo

oral

Intervention Type DRUG

Sulfonylurea

oral

Intervention Type DRUG

Other Intervention Names

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ASP1941 Glibenclamide Gliclazide Glimepiride

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetic patients receiving with sulfonylurea 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No