NCT01370707
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Metformin
- Conditions
- Diabetes Mellitus
- Sponsor
- HK inno.N Corporation
- Enrollment
- 187
- Locations
- 21
- Primary Endpoint
- Change from baseline in HbA1c at week 24
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.
Investigators
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
Arms & Interventions
Metformin
Intervention: Metformin
CJ-30001/CJ-30002
Intervention: CJ-30001/CJ-30002
Outcomes
Primary Outcomes
Change from baseline in HbA1c at week 24
Time Frame: Baseline, week 24
Secondary Outcomes
- Percentage of patients achieving HbA1c <6.5% at week 24(week 24)
- 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 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)
Study Sites (21)
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