Efficacy and Safety of Lobeglitazone Versus Sitagliptin

NCT ID: NCT02480465

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-03-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lobelitazone 0.5mg

Lobelitazone 0.5mg

Group Type: EXPERIMENTAL

Lobelitazone 0.5mg

Intervention Type: DRUG

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

Sitagliptin 100mg

Sitagliptin 100mg

Group Type: ACTIVE_COMPARATOR

Sitagliptin 100mg

Intervention Type: DRUG

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

Interventions

Lobelitazone 0.5mg

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

Intervention Type: DRUG

Sitagliptin 100mg

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dong-Sub Choi

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

Korea University Anam Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyun-Kyung Oh

Role: CONTACT

hkoh@ckdpharm.com

82-2-2194-0469

Facility Contacts

Dong-sub Choi

Role: primary

Other Identifiers

39DM14010

Identifier Type: -

Identifier Source: org_study_id