Efficacy and Safety of Lobeglitazone Versus Sitagliptin

Chong Kun Dang

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Sitagliptin 100mg; Drug: Lobelitazone 0.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02480465

39DM14010

Details and patient eligibility

About

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

Full 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.

Enrollment: 248 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

248 participants in 2 patient groups

Lobelitazone 0.5mg

Experimental group

Description:

Lobelitazone 0.5mg

Treatment:

Drug: Lobelitazone 0.5mg

Sitagliptin 100mg

Active Comparator group

Description:

Sitagliptin 100mg

Treatment:

Drug: Sitagliptin 100mg