Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus

NCT ID: NCT00532506

Last Updated: 2008-10-10

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

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in patients with Type2 Diabetes Mellitus

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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SK-0403

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Treatment-naive subjects diagnosed with type 2 diabetes mellitus
* Stable diet program for at least 8 weeks
* Criteria for HbA1c are met

Exclusion Criteria

* Type 1 diabetes
* Patients treated with other antidiabetic drugs or Insulin
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanwa Kagaku Kenkyusho Co., Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ryuzo Kawamori, M.D.

Role: STUDY_CHAIR

Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism

Locations

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Fukuoka, , Japan

Site Status

Gifu, , Japan

Site Status

Gunma, , Japan

Site Status

Hokkaido, , Japan

Site Status

Ibaraki, , Japan

Site Status

Kanagawa, , Japan

Site Status

Kumamoto, , Japan

Site Status

Okinawa, , Japan

Site Status

Ōita, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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DP1001

Identifier Type: -

Identifier Source: org_study_id