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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370707
• Other study ID #: CJ_VCM_301
• Status: Completed
• Phase: Phase 3
• First received: June 2, 2011
• Last updated: February 13, 2013
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 69 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Metformin
1000~1500mg/day, 24weeks
• CJ-30001/CJ-30002
0.6/1500mg~0.9/1500mg/day, 24weeks

Locations

Country	Name	City	State
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	Inje University Pusan Baik Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
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	Hallym University Medical Center(Gangnam)	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	Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c at week 24		Baseline, week 24	No
Secondary	Change from baseline in HbA1c, FPG, insulin and GLP-1 at week 4, 8, 12, 18, 24		Baseline, week 4, 8, 12, 18, 24	No
Secondary	Change from baseline in 2hr PPG and postprandial insulin at week 24		Baseline, week 24	No
Secondary	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	No
Secondary	Percentage of patients achieving HbA1c <7% at week 24		week 24	No
Secondary	Percentage of patients achieving HbA1c <6.5% at week 24		week 24	No
Secondary	Percentage of patients reaching FPG <126mg/dL at week 24		week 24	No
Secondary	Percentage of patients reaching 2hr PPG <200mg/dL at week 24		week 24	No
Secondary	Percentage of patients adjusting to the high dose		week 24	No
Secondary	Percentage of withdrawing patients due to uncontrolled glucose		week 24	No
Secondary	Change from baseline in serum lipid(T. cholesterol, HDL, LDL, TG) at week 24		week 24	No
Secondary	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	No