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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00532506
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : October 10, 2008
Information provided by:
Sanwa Kagaku Kenkyusho Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: SK-0403 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00532506

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.
Study Chair: Ryuzo Kawamori, M.D. Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism Identifier: NCT00532506     History of Changes
Other Study ID Numbers: DP1001
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: October 10, 2008
Last Verified: October 2008

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