A Dose-Finding, Efficacy and Safety Study of YY-351 in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine the dosage selected and to evaluate the efficacy and safety of YY-351.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuyu Pharma, Inc.

Criteria

Inclusion Criteria:

• Previous diagnosis of Type 2 diabetes(more than 3months)

• Patients aged over 18 years

• FPG levels in the range : 126 - 270mg/dL or HbA1c : 7.0 - 12.0%

Exclusion Criteria:

• Pregnant women, Breast feeding, or actively trying to be come pregnant

• Patients with Type 1 DM, gestational diabetes or secondary diabetes

• FPG levels in the range : ≥ 270mg/dL HbA1c : < 7.0, >12.0%

• Patient who take the medicine which may affect to blood sugar control (i.e.systemic glucocorticoid)

• Patients with diabetic complications or the history of a case that would affect to efficacy and safety evaluation (i.e. Thyroid disorder, Cushing's Syndrome, Multiple ovarian cystoma, pheochromocytoma)

• Patients with Chronic hepatitis, hepatitis B, C (except healthy HBV carrier) or Liver diseases (AST or/and ALT >2 × ULN(upper limit normal))

• Patients with Kidney disorder (Cr>2.0)