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

Phase 3

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Metformin; Drug: CJ-30001/CJ-30002

• Registration Number: NCT01370707
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	-
CJ-30001/CJ-30002	CJ-30001/CJ-30002	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c at week 24	Baseline, week 24

Secondary Outcome Measures

Name	Time	Method
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	Baseline, week 8, 18, 24	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

Trial Locations

Locations (21)

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

National Health Insurance Coporation Ilsan Hospital; 🇰🇷 Ilsan, Korea, Republic of

Kyungpook University Hospital; 🇰🇷 Daegu, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Eulji Medical Center; 🇰🇷 Seoul, Korea, Republic of

Uijeongbu St. Mary's Hospital; 🇰🇷 Uijeongbu, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, 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

Hallym University Medical Center(Gangdong); 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Hallym University Medical Center(Gangnam); 🇰🇷 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

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Inje University Pusan Baik Hospital; 🇰🇷 Pusan, Korea, Republic of