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A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects

NCT ID: NCT00454233

Last Updated: 2008-10-16

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

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these patients

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Keywords

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Diabetes Mellitus Type 2 YM543 Treatment Safety efficacy

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

Dose 1

Group Type EXPERIMENTAL

YM543

Intervention Type DRUG

Oral

2

Dose 2

Group Type EXPERIMENTAL

YM543

Intervention Type DRUG

Oral

3

Dose 3

Group Type EXPERIMENTAL

YM543

Intervention Type DRUG

Oral

4

Dose 4

Group Type EXPERIMENTAL

YM543

Intervention Type DRUG

Oral

5

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Oral

6

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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YM543

Oral

Intervention Type DRUG

Metformin

Oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Treatment-naive subjects diagnosed with T2DM
* Stable diet and exercise program for at least 6 weeks
* Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1

Exclusion Criteria

* Any known complication of T2DM indicating a late disease state, clinical manifestations of macro- and/or micro vascular disorders
* Use of insulin or oral blood glucose lowering drugs in the last 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma Europe BV

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

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4 Sites

Moscow, , Russia

Site Status

Nizhny Novgorod, , Russia

Site Status

Petrozavodsk, , Russia

Site Status

10 Sites

Saint Petersburg, , Russia

Site Status

Samara, , Russia

Site Status

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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EudraCT number: 2006-001110-33

Identifier Type: -

Identifier Source: secondary_id

543-CL-003

Identifier Type: -

Identifier Source: org_study_id