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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00532506
Other study ID # DP1001
Secondary ID
Status Completed
Phase Phase 2
First received September 19, 2007
Last updated October 8, 2008

Study information

Verified date October 2008
Source Sanwa Kagaku Kenkyusho Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind


Intervention

Drug:
SK-0403


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

Japan, 

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