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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Metformin; Drug: CJ-30001/CJ-30002

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Bucheon St. Mary's Hospital
  • Bundang, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Chonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daegu, Korea, Republic of
    • Kyungpook University Hospital
  • Ilsan, Korea, Republic of
    • National Health Insurance Coporation Ilsan Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Baik Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Seoul st. mary's hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of
    • Eulji Medical Center
  • Seoul, Korea, Republic of
    • Hallym University Medical Center(Gangdong)
  • Seoul, Korea, Republic of
    • Hallym University Medical Center(Gangnam)
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Uijeongbu, Korea, Republic of
    • Uijeongbu St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c at week 24	Baseline, week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in HbA1c, FPG, insulin and GLP-1 at week 4, 8, 12, 18, 24		Baseline, week 4, 8, 12, 18, 24
Change from baseline in 2hr PPG and postprandial insulin at week 24		Baseline, week 24
Change from baseline in FPG and HbA1c according to HbA1c at baseline(7~8%,8~9%, 9~10%, 10~11%)		Baseline, week 4, 8, 12, 18, 24
Percentage of patients achieving HbA1c <7% at week 24		week 24
Percentage of patients achieving HbA1c <6.5% at week 24		week 24
Percentage of patients reaching FPG <126mg/dL at week 24		week 24
Percentage of patients reaching 2hr PPG <200mg/dL at week 24		week 24
Percentage of patients adjusting to the high dose		week 24
Percentage of withdrawing patients due to uncontrolled glucose		week 24
Change from baseline in serum lipid(T. cholesterol, HDL, LDL, TG) at week 24		week 24
Glycemic variability	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	Baseline, week 8, 18, 24

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: June 2, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (ESTIMATE): June 10, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: CJ_VCM_301