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Efficacy and Safety of Lobeglitazone Versus Sitagliptin

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ClinicalTrials.gov Identifier: NCT02480465
Recruitment Status : Unknown
Verified May 2015 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : June 24, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Lobelitazone 0.5mg Drug: Sitagliptin 100mg Phase 4

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  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lobelitazone 0.5mg
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
Sitagliptin 100mg
Drug: Sitagliptin 100mg
placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin




Primary Outcome Measures :
  1. The mean percent change of HbA1c [ Time Frame: from baseline at 24 weeks ]

Secondary Outcome Measures :
  1. The rate of Metabolic Syndrome [ Time Frame: from baseline at 24 weeks ]
  2. The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line) [ Time Frame: from baseline at 24 weeks ]
  3. The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI) [ Time Frame: from baseline at 24 weeks ]
  4. The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B) [ Time Frame: from baseline at 24 weeks ]
  5. The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%) [ Time Frame: from baseline at 24 weeks ]
  6. The mean percent change of Adiponectin [ Time Frame: from baseline at 24 weeks ]
  7. The mean percent change of hs-CRP [ Time Frame: from baseline at 24 weeks ]
  8. Safety evaluation - physical examination, vital sign, laboratory, adverse event [ Time Frame: from baseline at 24 weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480465


Contacts
Contact: Hyun-Kyung Oh 82-2-2194-0469 hkoh@ckdpharm.com

Locations
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong-sub Choi         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Dong-Sub Choi Korea University Anam Hospital

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02480465     History of Changes
Other Study ID Numbers: 39DM14010
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action