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

HK inno.N

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus

Treatments

Drug: Metformin

Drug: CJ-30001/CJ-30002

Study type

Interventional

Funder types

Industry

Identifiers

CJ_VCM_301

Details and patient eligibility

About

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

Enrollment

187 patients

Sex

All

Ages

20 to 69 years old

Volunteers

No Healthy Volunteers

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