Clinical trial NCT01370707: A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 187
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline in HbA1c at week 24
timeFrame: Baseline, week 24
Secondary outcomes:
measure: Change from baseline in HbA1c, FPG, insulin and GLP-1 at week 4, 8, 12, 18, 24
timeFrame: Baseline, week 4, 8, 12, 18, 24
measure: Change from baseline in 2hr PPG and postprandial insulin at week 24
timeFrame: Baseline, week 24
measure: Change from baseline in FPG and HbA1c according to HbA1c at baseline(7~8%,8~9%, 9~10%, 10~11%)
timeFrame: Baseline, week 4, 8, 12, 18, 24
measure: Percentage of patients achieving HbA1c <7% at week 24
timeFrame: week 24
measure: Percentage of patients achieving HbA1c <6.5% at week 24
timeFrame: week 24
measure: Percentage of patients reaching FPG <126mg/dL at week 24
timeFrame: week 24
measure: Percentage of patients reaching 2hr PPG <200mg/dL at week 24
timeFrame: week 24
measure: Percentage of patients adjusting to the high dose
timeFrame: week 24
measure: Percentage of withdrawing patients due to uncontrolled glucose
timeFrame: week 24
measure: Change from baseline in serum lipid(T. cholesterol, HDL, LDL, TG) at week 24
timeFrame: week 24
measure: Glycemic variability
timeFrame: Baseline, week 8, 18, 24
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Chonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Coporation Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Baik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center(Gangdong)
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center(Gangnam)
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
Study officials:
References: