Efficacy and Safety of Lobeglitazone Versus Sitagliptin

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Lobelitazone 0.5mg; Drug: Sitagliptin 100mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Dong-sub Choi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lobelitazone 0.5mg	Drug: Lobelitazone 0.5mg; Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
ACTIVE_COMPARATOR: Sitagliptin 100mg	Drug: Sitagliptin 100mg; placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Dong-Sub Choi, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): March 1, 2017

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (ESTIMATE): June 24, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 6, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 39DM14010