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
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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
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
NCT ID
NCT02480465
First Posted
June 22, 2015
Last Updated
July 6, 2015
Sponsor
Chong Kun Dang Pharmaceutical
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
Learn more about this trial
Efficacy and Safety of Lobeglitazone Versus Sitagliptin
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