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

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

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Metformin
* Drug: CJ-30001/CJ-30002


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br> | Drug: Metformin<br>* 1000 1500mg/day, 24weeks<br>|
| Experimental: CJ-30001/CJ-30002<br> | Drug: CJ-30001/CJ-30002<br>* 0.6/1500mg 0.9/1500mg/day, 24weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |