Inadequate Glucose Control, Type 2 Diabetes Mellitus
Conditions
Brief summary
Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie
Detailed description
This study is a double blind, randomized, investigator initiated study on glucose-lowering effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy. The primary aim of the study is to compared changes of HbA1c between 0.25mg robeblitazone add-on group and 0.5mg robeglitazone add-on group.
Interventions
DRUGduvie
take the intervention drug once daily according to the randomized groups
Sponsors
Chong Kun Dang Pharmaceutical Corp.
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Type Ⅱ diabetes mellitus 2. Between 19 years and 80 years old 3. BMI between 20kg/㎡ to 45kg/㎡ 4. Among those using Metformin and DPP-4 inhibitor merging therapy for more than 3 months, A person who has not changed the dosage of Metformin 500 mg and DPP-4 inhibitor for more than 8 weeks at the time of screening 5. HbA1c 7.0 to 9.0 6. Agreement with written informed consent
Exclusion criteria
1. Historical history of severe heart failure or heart failure (NYHA Class III&IV) 2. Rapid coronary syndrome, cardiovascular interventions within 6 months 3. History of cerebral vascular diseases within six months 4. High blood pressure uncontrolled (\>160/100 mmHg) 5. In case weight loss drug is used within 3 months 6. In case of systemic corticosteroids treatment within 3 months 7. If there is an allergy or overreaction to the study drug or its components 8. In case of acute metabolic complications (ketonicemia or high osmotic pressure) within 6 months 9. Anemia Hb \< 12g/dL(male), 10g/dL(female) 10. Kidney function GFR \< 45mL/min/1.73m2 (GFR test results are calculated by the Cockcroft-Gault Calculator). 11. impaired hepatic function (AST/ALT 2.5-fold the upper limit of the normal range \[ULN\]) 12. TG\>500 mg/dL 13. LDL cholesterol \>160 mg/dL \- If a lipid-lowering agent is being taken, the existing dose should be taken during the study period. 14. The thyroid hormone is within its normal range \- however, thyroid hormone may be registered at the discretion of the investigator even if it is outside the normal range. 15. Laser treatment for proliferative retinopathy within 6 months 16. history of alcohol or drug abuse in the previous 3 months 17. history of most cancers not in remission for 5 years 18. Past history of bladder cancer 19. Women nursing or pregnant Persons who are not using effective contraceptive methods, or who refuse to use contraceptives as specified below (permitted contraceptives: condoms, castings, or implantation contraceptives, etc.) are installed with contraceptives in the uterus 20. external injury, acute infections, a history/presence of any other severe disease, or severe trauma 21. Patients who use basins - however, they can be registered by stopping 8 weeks before the start of administration of medicines for clinical trials 22. A person who has used endemic insulin for more than 7 days in the last 8 weeks 23. A person with the drug usage in the TZD series over the last eight weeks. 24. When experiencing allergies, hypersensitivity, or side effects associated with drug use in the TZD series; 25. The researcher determines that other participants may experience difficulties in participating in the test through to the end, or that participation in the test may result in additional risks or confusion in the test results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c at 24 week | 24 week | changes of HbA1c between baseline and 24 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lipid levels | 24 week | changes of lipid levels between baseline and 24 week |
| hs-CRP | 24 week | changes of hs-CRP between baseline and 24 week |
| AST | 24 week | changes of AST between baseline and 24 week |
| adiponectin | 24 week | changes of adiponectin between baseline and 24 week |
| HOMA-IR | 24 week | changes of HOMA-IR between baseline and 24 week |
| ALT | 24 week | changes of ALT between baseline and 24 week |
| ALP | 24 week | changes of ALP between baseline and 24 week |
| total bilirubin | 24 week | changes of total bilirubin between baseline and 24 week |
| adverse event (weight gain,edema) | 24 week | changes of adverse event (weight gain,edema) between baseline and 24 week |
Countries
South Korea
Outcome results
None listed