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

June 2, 2011
February 13, 2013
April 2011
July 2012   (final data collection date for primary outcome measure)
Change from baseline in HbA1c at week 24 [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01370707 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: Metformin
    1000~1500mg/day, 24weeks
  • Drug: CJ-30001/CJ-30002
    0.6/1500mg~0.9/1500mg/day, 24weeks
  • Active Comparator: Metformin
    Intervention: Drug: Metformin
  • Experimental: CJ-30001/CJ-30002
    Intervention: Drug: CJ-30001/CJ-30002
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01370707
CJ_VCM_301
No
CJ Cheiljedang Corporation
CJ Cheiljedang Corporation
Not Provided
Not Provided
CJ Cheiljedang Corporation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP