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Efficacy and Safety of Lobeglitazone Versus Sitagliptin

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lobelitazone 0.5mg
Sitagliptin 100mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lobelitazone 0.5mg

Sitagliptin 100mg

Arm Description

Lobelitazone 0.5mg

Sitagliptin 100mg

Outcomes

Primary Outcome Measures

The mean percent change of HbA1c

Secondary Outcome Measures

The rate of Metabolic Syndrome
The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)
The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI)
The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B)
The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)
The mean percent change of Adiponectin
The mean percent change of hs-CRP
Safety evaluation - physical examination, vital sign, laboratory, adverse event

Full Information

First Posted
June 22, 2015
Last Updated
July 6, 2015
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02480465
Brief Title
Efficacy and Safety of Lobeglitazone Versus Sitagliptin
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lobelitazone 0.5mg
Arm Type
Experimental
Arm Description
Lobelitazone 0.5mg
Arm Title
Sitagliptin 100mg
Arm Type
Active Comparator
Arm Description
Sitagliptin 100mg
Intervention Type
Drug
Intervention Name(s)
Lobelitazone 0.5mg
Intervention Description
Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100mg
Intervention Description
placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
Primary Outcome Measure Information:
Title
The mean percent change of HbA1c
Time Frame
from baseline at 24 weeks
Secondary Outcome Measure Information:
Title
The rate of Metabolic Syndrome
Time Frame
from baseline at 24 weeks
Title
The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)
Time Frame
from baseline at 24 weeks
Title
The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI)
Time Frame
from baseline at 24 weeks
Title
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
Title
The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)
Time Frame
from baseline at 24 weeks
Title
The mean percent change of Adiponectin
Time Frame
from baseline at 24 weeks
Title
The mean percent change of hs-CRP
Time Frame
from baseline at 24 weeks
Title
Safety evaluation - physical examination, vital sign, laboratory, adverse event
Time Frame
from baseline at 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥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 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 AST and/or ALT ≥ 3*ULN Serum creatinine: male ≥ 1.5mg/dl, female ≥ 1.4mg/dl 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Kyung Oh
Phone
82-2-2194-0469
Email
hkoh@ckdpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Sub Choi
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-sub Choi

12. IPD Sharing Statement

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Efficacy and Safety of Lobeglitazone Versus Sitagliptin

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