A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients
Overview[ - collapse ][ - ]
Purpose | The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002. |
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Condition | Diabetes Mellitus |
Intervention | Drug: Metformin Drug: CJ-30001/CJ-30002 |
Phase | Phase 3 |
Sponsor | CJ Cheiljedang Corporation |
Responsible Party | CJ Cheiljedang Corporation |
ClinicalTrials.gov Identifier | NCT01370707 |
First Received | June 2, 2011 |
Last Updated | February 13, 2013 |
Last verified | February 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | June 2, 2011 |
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Last Updated Date | February 13, 2013 |
Start Date | April 2011 |
Estimated Primary Completion Date | July 2012 |
Current Primary Outcome Measures | Change from baseline in HbA1c at week 24 [Time Frame: Baseline, week 24] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients |
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Official Title | 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 |
Brief Summary | The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Diabetes Mellitus |
Intervention | Drug: Metformin 1000~1500mg/day, 24weeks Drug: CJ-30001/CJ-30002 0.6/1500mg~0.9/1500mg/day, 24weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 187 |
Estimated Completion Date | July 2012 |
Estimated Primary Completion Date | July 2012 |
Eligibility 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 |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01370707 |
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Other Study ID Numbers | CJ_VCM_301 |
Has Data Monitoring Committee | No |
Information Provided By | CJ Cheiljedang Corporation |
Study Sponsor | CJ Cheiljedang Corporation |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | February 2013 |
Locations[ + expand ][ + ]
Bucheon St. Mary's Hospital | Bucheon, Korea, Republic of |
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Seoul National University Bundang Hospital | Bundang, Korea, Republic of |
Chonbuk National University Hospital | Chonju, Korea, Republic of |
Kyungpook University Hospital | Daegu, Korea, Republic of |
Yeungnam University Medical Center | Daegu, Korea, Republic of |
National Health Insurance Coporation Ilsan Hospital | Ilsan, Korea, Republic of |
Inha University Hospital | Incheon, Korea, Republic of |
Pusan National University Hospital | Pusan, Korea, Republic of |
Inje University Pusan Baik Hospital | Pusan, Korea, Republic of |
Asan Medical Center | Seoul, Korea, Republic of |
Hallym University Medical Center(Gangnam) | Seoul, Korea, Republic of |
Seoul St. Mary's hospital | Seoul, Korea, Republic of |
Severance Hospital | Seoul, Korea, Republic of |
Kangbuk Samsung Hospital | Seoul, Korea, Republic of |
Korea University Guro Hospital | Seoul, Korea, Republic of |
Samsung Medical Center | Seoul, Korea, Republic of |
Eulji Medical Center | Seoul, Korea, Republic of |
Hallym University Medical Center(Gangdong) | Seoul, Korea, Republic of |
Kyung Hee University Hospital | Seoul, Korea, Republic of |
Ajou University Hospital | Suwon, Korea, Republic of |
Uijeongbu St. Mary's Hospital | Uijeongbu, Korea, Republic of |