Efficacy and Safety of Lobeglitazone Versus Sitagliptin

Study Overview
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Brief Summary
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Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.

Detailed Description
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Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study.

Official Title
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Efficacy and Safety of Lobeglitazone Versus Sitagliptin in Inadequately Controlled by Metformin Alone Type 2 Diabetes Mellitus Patients With Metabolic Syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Lobelitazone 0.5mg
* Drug: Sitagliptin 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥19 years old Waist line: male ≥ 90cm, female ≥ 85cm Applied to 1 or more categories listed below (NCEP-ATP III) SBP ≥ 130mmHg and/or DBP ≥ 85mmHg and/or taking drug for BP control HDL-C: male < 40mg/dl, female < 50mg/dl and/or taking drug for HDL-C increase TG ≥ 150mg/dl and/or taking drug for TG control At visit 1: Applied to 1 or more categories listed below Type 2 DM Patients who does not need stabilization period : 7% ≤ HbA1c ≤ 10%, if treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study → Visit 3(Randomization) Type 2 DM Patients who need stabilization period : 7% ≤ HbA1c ≤ 10%, if not treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study (Applied to 1 or more categories listed below) ① Drug Naïve ② Taking Metformin < 1000mg monotherapy and/or Taking Metformin < 12 weeks prior to this study ③ Taking OHA At visit 2(After 12 weeks of stabilization period): 7% ≤ HbA1c ≤ 10% Patients who signed informed consent form Exclusion Criteria: Type 1 DM Patients or secondary DM Patients with ketoacidosis Patients with taking insulin > 7 days within 12 weeks Hypersensitive to biguanide and/or glitazone and/or DPP4-inhibitor Patients with taking corticosteroid > 7 days within 4 weeks Patients with lactic acidosis Patients with galactose intolerance and/or Lapp lactase deficiency and/or glucose-galactose malabsorption Patients with innutrition and/or starvation and/or weakness and/or pituitary insufficiency and/or addisons disease History of malignant tumor within 5 years History of drug or alcohol abuse within 12 weeks Patients with congestive heart failure(NYHA class III IV) or uncontrolled arrythmia within 6 months Patients with acute cardiovasvular disaese with 12 weeks Applied to 1 or more categories listed below AST and/or ALT ≥ 3*ULN Serum creatinine: male ≥ 1.5mg/dl, female ≥ 1.4mg/dl Hb < 10.5g/dl Women with pregnant, breast-feeding Childbearing age who don't use adequate contraception Patients who have participated in other clinical trials Not eligible to participate for the study at the discretion of investigator

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Experimental: Lobelitazone 0.5mg<br>Lobelitazone 0.5mg | Drug: Lobelitazone 0.5mg<br>* Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin<br>|
| Active Comparator: Sitagliptin 100mg<br>Sitagliptin 100mg | Drug: Sitagliptin 100mg<br>* placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean percent change of HbA1c |  | from baseline at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of Metabolic Syndrome |  | from baseline at 24 weeks | 
| The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line) |  | from baseline at 24 weeks | 
| The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI) |  | from baseline at 24 weeks | 
| The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B) |  | from baseline at 24 weeks | 
| The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%) |  | from baseline at 24 weeks | 
| The mean percent change of Adiponectin |  | from baseline at 24 weeks | 
| The mean percent change of hs-CRP |  | from baseline at 24 weeks | 
| Safety evaluation - physical examination, vital sign, laboratory, adverse event |  | from baseline at 24 weeks |