Efficacy and Safety of Lobeglitazone Versus Sitagliptin

Chong Kun Dang Pharmaceutical248 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

248

Conditions

Diabetes Mellitus, Type 2

Interventions

Lobelitazone 0.5mgDRUG

Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin

Sitagliptin 100mgDRUG

placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥19 years old * Waist line: male ≥ 90cm, female ≥ 85cm * Applied to 1 or more categories listed below (NCEP-ATP III) 1. SBP ≥ 130mmHg and/or DBP ≥ 85mmHg and/or taking drug for BP control 2. HDL-C: male \< 40mg/dl, female \< 50mg/dl and/or taking drug for HDL-C increase 3. TG ≥ 150mg/dl and/or taking drug for TG control * At visit 1: Applied to 1 or more categories listed below 1. 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) 2. 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 1. AST and/or ALT ≥ 3\*ULN 2. Serum creatinine: male ≥ 1.5mg/dl, female ≥ 1.4mg/dl 3. 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

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING