Diabetes Mellitus, Type 2
Conditions
Brief summary
Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.
Detailed description
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.
Interventions
DRUGLobelitazone 0.5mg
Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean percent change of HbA1c | from baseline at 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 rate of Metabolic Syndrome | 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 |
| The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%) | from baseline at 24 weeks |
Countries
South Korea
Contacts
Primary ContactHyun-Kyung Oh
Outcome results
None listed