A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients

A Randomized, Double-blind, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Patients With Type 2 Diabetes and Inadequate Glycemic Control ; Phase III Study

The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.

Inclusion Criteria:

• Subjects with Type 2 Diabetes Mellitus
• 20~69 years old
• BMI < 30kg/m2
• HbA1c between 7% and 11%
• receiving no oral antihyperglycemic agent for more than seven days for at least 8 weeks
• Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

• Subjects with Type 1 Diabetes Mellitus
• FPG > 270mg/dL
• Subjects having insulin treatment
• Subjects with acute or chornic metaboic acidosis
• Subjects with cardiovascular disease
• Subjects with chronic GI disease
• Subjects with a history of substance or alchol abuse within 1 year
• Subjects with a history of hypersensitivity to biguanide or a-GI
• Subjects with hypopituitarism or hypocorticalism
• Subjects with cancer
• Subjects who take corticosteriods or plan to take corticosteroid
• AST and ALT > 2.5 times the upper limit of normal
• Creatinine level > 1.5mg/dL in male and 1.4mg/dL in female
• SBP > 150mmHg or DBP > 90mmHg
• Subjects who work the night shift
• Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
• Subjects who have participated in other study within 3 months
• Subjects judged to be unsuitable for this trial by investigator