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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CJ Cheiljedang Corporation

ClinicalTrials.gov Identifier:

NCT01370707

First received: June 2, 2011

Last updated: February 13, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 2, 2011
Last Updated Date	February 13, 2013
Start Date ^ICMJE	April 2011
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 9, 2011)	Change from baseline in HbA1c at week 24 [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01370707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 13, 2013)	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
Original Secondary Outcome Measures ^ICMJE (submitted: June 9, 2011)	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: Yes ] 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
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Diabetes Mellitus
Intervention ^ICMJE	Drug: Metformin 1000~1500mg/day, 24weeks Drug: CJ-30001/CJ-30002 0.6/1500mg~0.9/1500mg/day, 24weeks
Study Arm (s)	Active Comparator: Metformin Intervention: Drug: Metformin Experimental: CJ-30001/CJ-30002 Intervention: Drug: CJ-30001/CJ-30002
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	187
Completion Date	July 2012
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 to 69 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01370707
Other Study ID Numbers ^ICMJE	CJ_VCM_301
Has Data Monitoring Committee	No
Responsible Party	CJ Cheiljedang Corporation
Study Sponsor ^ICMJE	CJ Cheiljedang Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	CJ Cheiljedang Corporation
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top