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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Metformin

Criteria

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