Efficacy and Safety of Lobeglitazone Versus Sitagliptin

NCT02480465 | Unknown Phase 4

• 1 other identifier: 39DM14010
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• The mean percent change of HbA1c

  from baseline at 24 weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

Lobelitazone 0.5mg

EXPERIMENTAL

Lobelitazone 0.5mg

Drug: Lobelitazone 0.5mg

Sitagliptin 100mg

ACTIVE COMPARATOR

Sitagliptin 100mg

Drug: Sitagliptin 100mg

Interventions

Lobelitazone 0.5mg DRUG

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

Lobelitazone 0.5mg

Sitagliptin 100mg DRUG

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

Sitagliptin 100mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥19 years old
• Waist line: male ≥ 90cm, female ≥ 85cm
• Applied to 1 or more categories listed below (NCEP-ATP III)
• SBP ≥ 130mmHg and/or DBP ≥ 85mmHg and/or taking drug for BP control
• HDL-C: male \< 40mg/dl, female \< 50mg/dl and/or taking drug for HDL-C increase
• TG ≥ 150mg/dl and/or taking drug for TG control
• At visit 1: Applied to 1 or more categories listed below
• 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)
• 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

You may not qualify if:

• 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
• AST and/or ALT ≥ 3\*ULN
• Serum creatinine: male ≥ 1.5mg/dl, female ≥ 1.4mg/dl

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Dong-Sub Choi

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Kyung Oh

CONTACT

82-2-2194-0469; hkoh@ckdpharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 24, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 8, 2015

Record last verified: 2015-05

Locations

KR (1)