A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients
NCT ID: NCT01370707
Last Updated: 2013-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
187 participants
INTERVENTIONAL
2011-04-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Metformin
Metformin
1000\~1500mg/day, 24weeks
CJ-30001/CJ-30002
CJ-30001/CJ-30002
0.6/1500mg\~0.9/1500mg/day, 24weeks
Interventions
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Metformin
1000\~1500mg/day, 24weeks
CJ-30001/CJ-30002
0.6/1500mg\~0.9/1500mg/day, 24weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
69 Years
ALL
No
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Locations
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Bucheon St. Mary's Hospital
Bucheon-si, , South Korea
Seoul National University Bundang Hospital
Bundang, , South Korea
Kyungpook University Hospital
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
National Health Insurance Coporation Ilsan Hospital
Ilsan, , South Korea
Inha University Hospital
Incheon, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Inje University Pusan Baik Hospital
Pusan, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Eulji Medical Center
Seoul, , South Korea
Hallym University Medical Center(Gangdong)
Seoul, , South Korea
Hallym University Medical Center(Gangnam)
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St. Mary's hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Uijeongbu St. Mary's Hospital
Uijeongbu-si, , South Korea
Countries
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Other Identifiers
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CJ_VCM_301
Identifier Type: -
Identifier Source: org_study_id
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