A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

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

PHASE2

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-26

Study Completion Date

2009-03-14

Brief Summary

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The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus

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Detailed Description

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Conditions

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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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1

Lowest dose

Group Type EXPERIMENTAL

ipragliflozin

Intervention Type DRUG

Oral

2

Low-middle dose

Group Type EXPERIMENTAL

ipragliflozin

Intervention Type DRUG

Oral

3

High-middle dose

Group Type EXPERIMENTAL

ipragliflozin

Intervention Type DRUG

Oral

4

Highest dose

Group Type EXPERIMENTAL

ipragliflozin

Intervention Type DRUG

Oral

5

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

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ipragliflozin

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Other Intervention Names

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ASP1941

Eligibility Criteria

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Inclusion Criteria

* Established diagnosis of type 2 diabetes mellitus
* Fasting serum C-peptide level \> 0.6 ng/mL
* HbA1c between 7.0 and 10.0%
* Body Mass Index between 20 and 45 kg/m2

Exclusion Criteria

* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300 mg/g)
* Dysuria and/or urinary tract infection
* Significant renal, hepatic or cardiovascular diseases
* Ketosis
* Hypertension
* Severe gastrointestinal diseases

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No