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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 HealthCare Corporation
ClinicalTrials.gov Identifier:
NCT01370707
First received: June 2, 2011
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Drug: Metformin
Drug: CJ-30001/CJ-30002
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by CJ HealthCare Corporation:

Primary Outcome Measures:
  • Change from baseline in HbA1c at week 24 [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]

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


Enrollment: 187
Study Start Date: April 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin Drug: Metformin
1000~1500mg/day, 24weeks
Experimental: CJ-30001/CJ-30002 Drug: CJ-30001/CJ-30002
0.6/1500mg~0.9/1500mg/day, 24weeks

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370707

Locations
Korea, Republic of
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
Severance Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Eulji Medical Center
Seoul, Korea, Republic of
Hallym University Medical Center(Gangdong)
Seoul, Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul St. Mary's hospital
Seoul, Korea, Republic of
Hallym University Medical Center(Gangnam)
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Uijeongbu St. Mary's Hospital
Uijeongbu, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
  More Information

No publications provided

Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT01370707     History of Changes
Other Study ID Numbers: CJ_VCM_301
Study First Received: June 2, 2011
Last Updated: February 13, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014