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

October 8, 2008 updated by: Sanwa Kagaku Kenkyusho Co., Ltd.
The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in patients with Type2 Diabetes Mellitus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
      • Gifu, Japan
      • Gunma, Japan
      • Hokkaido, Japan
      • Ibaragi, Japan
      • Kanagawa, Japan
      • Kumamoto, Japan
      • Oita, Japan
      • Okinawa, Japan
      • Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Investigators

  • Study Chair: Ryuzo Kawamori, M.D., Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Estimate)

October 10, 2008

Last Update Submitted That Met QC Criteria

October 8, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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