Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus
1 other identifier
interventional
N/A
1 country
10
Brief Summary
The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in patients with Type2 Diabetes Mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2007
CompletedFirst Posted
Study publicly available on registry
September 20, 2007
CompletedOctober 10, 2008
October 1, 2008
September 19, 2007
October 8, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Treatment-naive subjects diagnosed with type 2 diabetes mellitus
- Stable diet program for at least 8 weeks
- Criteria for HbA1c are met
You may not qualify if:
- Type 1 diabetes
- Patients treated with other antidiabetic drugs or Insulin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Fukuoka, Japan
Unknown Facility
Gifu, Japan
Unknown Facility
Gunma, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Ibaraki, Japan
Unknown Facility
Kanagawa, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Okinawa, Japan
Unknown Facility
Ōita, Japan
Unknown Facility
Tokyo, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ryuzo Kawamori, M.D.
Juntendo University School of Medicine, Dept. of Endocrinology and Metabolism
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 19, 2007
First Posted
September 20, 2007
Last Updated
October 10, 2008
Record last verified: 2008-10