Diabetes Mellitus
Conditions
Brief summary
The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.
Interventions
DRUGMetformin
1000\ 1500mg/day, 24weeks
DRUGCJ-30001/CJ-30002
0.6/1500mg\ 0.9/1500mg/day, 24weeks
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at week 24 | Baseline, week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change from baseline in HbA1c, FPG, insulin and GLP-1 at week 4, 8, 12, 18, 24 | Baseline, week 4, 8, 12, 18, 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 |
| Percentage of patients reaching 2hr PPG <200mg/dL at week 24 | week 24 | — |
Countries
South Korea
Outcome results
None listed