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.
ConditionDiabetes Mellitus
InterventionDrug: Metformin
Drug: CJ-30001/CJ-30002
PhasePhase 3
SponsorCJ Cheiljedang Corporation
Responsible PartyCJ Cheiljedang Corporation
ClinicalTrials.gov IdentifierNCT01370707
First ReceivedJune 2, 2011
Last UpdatedFebruary 13, 2013
Last verifiedFebruary 2013

Tracking Information[ + expand ][ + ]

First Received DateJune 2, 2011
Last Updated DateFebruary 13, 2013
Start DateApril 2011
Estimated Primary Completion DateJuly 2012
Current Primary Outcome MeasuresChange from baseline in HbA1c at week 24 [Time Frame: Baseline, week 24] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change from baseline in HbA1c, FPG, insulin and GLP-1 at week 4, 8, 12, 18, 24 [Time Frame: Baseline, week 4, 8, 12, 18, 24] [Designated as safety issue: No]
  • Change from baseline in 2hr PPG and postprandial insulin at week 24 [Time Frame: Baseline, week 24] [Designated as safety issue: No]
  • Change from baseline in FPG and HbA1c according to HbA1c at baseline(7~8%,8~9%, 9~10%, 10~11%) [Time Frame: Baseline, week 4, 8, 12, 18, 24] [Designated as safety issue: No]
  • Percentage of patients achieving HbA1c <7% at week 24 [Time Frame: week 24] [Designated as safety issue: No]
  • Percentage of patients achieving HbA1c <6.5% at week 24 [Time Frame: week 24] [Designated as safety issue: No]
  • Percentage of patients reaching FPG <126mg/dL at week 24 [Time Frame: week 24] [Designated as safety issue: No]
  • Percentage of patients reaching 2hr PPG <200mg/dL at week 24 [Time Frame: week 24] [Designated as safety issue: No]
  • Percentage of patients adjusting to the high dose [Time Frame: week 24] [Designated as safety issue: No]
  • Percentage of withdrawing patients due to uncontrolled glucose [Time Frame: week 24] [Designated as safety issue: No]
  • Change from baseline in serum lipid(T. cholesterol, HDL, LDL, TG) at week 24 [Time Frame: week 24] [Designated as safety issue: No]
  • Glycemic variability [Time Frame: Baseline, week 8, 18, 24] [Designated as safety issue: No]Glycemic variability is measured by M-value. M-value = ∑{/10*log(blood glucose/100)/3}/n+{Max(blood glucose)-Min(blood glucose)}/20, M<19: good, 19≤M<32: fair, 32≤M: poor

Descriptive Information[ + expand ][ + ]

Brief TitleA Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionDiabetes Mellitus
InterventionDrug: Metformin
1000~1500mg/day, 24weeks
Drug: CJ-30001/CJ-30002
0.6/1500mg~0.9/1500mg/day, 24weeks
Study Arm (s)
  • Active Comparator: Metformin
  • Experimental: CJ-30001/CJ-30002

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment187
Estimated Completion DateJuly 2012
Estimated Primary Completion DateJuly 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
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01370707
Other Study ID NumbersCJ_VCM_301
Has Data Monitoring CommitteeNo
Information Provided ByCJ Cheiljedang Corporation
Study SponsorCJ Cheiljedang Corporation
CollaboratorsNot Provided
Investigators Not Provided
Verification DateFebruary 2013

Locations[ + expand ][ + ]

Bucheon St. Mary's Hospital
Bucheon, Korea, Republic of
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