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

This study has been completed.
Sponsor:
Information provided by:
Sanwa Kagaku Kenkyusho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00532506
First received: September 19, 2007
Last updated: October 8, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: SK-0403
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by Sanwa Kagaku Kenkyusho Co., Ltd.:

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532506

Locations
Japan
Fukuoka, Japan
Gifu, Japan
Gunma, Japan
Hokkaido, Japan
Ibaragi, Japan
Kanagawa, Japan
Kumamoto, Japan
Oita, Japan
Okinawa, Japan
Tokyo, Japan
Sponsors and Collaborators
Sanwa Kagaku Kenkyusho Co., Ltd.
Investigators
Study Chair: Ryuzo Kawamori, M.D. Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00532506     History of Changes
Other Study ID Numbers: DP1001
Study First Received: September 19, 2007
Last Updated: October 8, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014