Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie

Study Overview
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Brief Summary
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Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie

Detailed Description
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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.

Official Title
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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

Conditions
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Inadequate Glucose Control, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: duvie


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type Ⅱ diabetes mellitus Between 19 years and 80 years old BMI between 20kg/㎡ to 45kg/㎡ 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 HbA1c 7.0 to 9.0 Agreement with written informed consent Exclusion Criteria: Historical history of severe heart failure or heart failure (NYHA Class III&IV) Rapid coronary syndrome, cardiovascular interventions within 6 months History of cerebral vascular diseases within six months High blood pressure uncontrolled (>160/100 mmHg) In case weight loss drug is used within 3 months In case of systemic corticosteroids treatment within 3 months If there is an allergy or overreaction to the study drug or its components In case of acute metabolic complications (ketonicemia or high osmotic pressure) within 6 months Anemia Hb < 12g/dL(male), 10g/dL(female) Kidney function GFR < 45mL/min/1.73m2 (GFR test results are calculated by the Cockcroft-Gault Calculator). impaired hepatic function (AST/ALT 2.5-fold the upper limit of the normal range [ULN]) TG>500 mg/dL LDL cholesterol >160 mg/dL - If a lipid-lowering agent is being taken, the existing dose should be taken during the study period. 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. Laser treatment for proliferative retinopathy within 6 months history of alcohol or drug abuse in the previous 3 months history of most cancers not in remission for 5 years Past history of bladder cancer 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 external injury, acute infections, a history/presence of any other severe disease, or severe trauma Patients who use basins - however, they can be registered by stopping 8 weeks before the start of administration of medicines for clinical trials A person who has used endemic insulin for more than 7 days in the last 8 weeks A person with the drug usage in the TZD series over the last eight weeks. When experiencing allergies, hypersensitivity, or side effects associated with drug use in the TZD series; 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.25mg robeglitazone add-on group<br>0.25mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy | Drug: duvie<br>* take the intervention drug once daily according to the randomized groups<br>|
| Active Comparator: 0.5mg robeglitazone add-on group<br>0.5mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy | Drug: duvie<br>* take the intervention drug once daily according to the randomized groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c at 24 week | changes of HbA1c between baseline and 24 week | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA-IR | changes of HOMA-IR between baseline and 24 week | 24 week | 
| lipid levels | changes of lipid levels between baseline and 24 week | 24 week | 
| hs-CRP | changes of hs-CRP between baseline and 24 week | 24 week | 
| AST | changes of AST between baseline and 24 week | 24 week | 
| adiponectin | changes of adiponectin between baseline and 24 week | 24 week | 
| adverse event (weight gain,edema) | changes of adverse event (weight gain,edema) between baseline and 24 week | 24 week | 
| ALT | changes of ALT between baseline and 24 week | 24 week | 
| ALP | changes of ALP between baseline and 24 week | 24 week | 
| total bilirubin | changes of total bilirubin between baseline and 24 week | 24 week |