An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus
2 other identifiers
interventional
173
1 country
9
Brief Summary
The purpose of this study is to evaluate and confirm hypoglycemic efficacy and safety of CKD-501 as mono therapy in patients with type 2 diabetes treated once daily for 24 weeks in comparison to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Oct 2009
Typical duration for phase_3 diabetes-mellitus-type-2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 23, 2009
CompletedFirst Posted
Study publicly available on registry
October 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 19, 2013
July 1, 2013
2.3 years
October 23, 2009
July 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Glycosylated Hemoglobin (HbA1c)
24 weeks
Secondary Outcomes (4)
Change from baseline in HbA1c target achievement rate (HbA1c<7%)
24 weeks
Change from baseline in lipid parameters (Total cholesterol, Triglycerides(TG), LDL-C, HDL-C, Small Dense LDL-C, Free fatty acid(FFA), Apo-AⅠ/B/C Ⅲ)
24 weeks
Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse event and so on
24 weeks or 52 weeks
Change from baseline in glycemic parameters (Fasting Plasma Glucose, C-peptide, Homeostasis Model Assessment of Insulin Resistance(HOMA-IR), Homeostasis Model Assessment of β-cell function(HOMA-β), Quantitative Insulin Check Index(QUICKI))
24 weeks
Study Arms (2)
CKD-501 0.5mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
0.5 mg/tablet, orally, 1 tablet once daily for 24 weeks or 52 weeks (If extension study)
Eligibility Criteria
You may qualify if:
- Type Ⅱ diabetes mellitus
- Between 18 years and 80 years old
- The patient who has been taking oral hypoglycemic agent since 3 months with HbA1c 6.5 to 9% at screening test or who is drug naive or stopped taking oral hypoglycemic agent more then 3 months with HbA1c 7 to 10% at screening test
- BMI between 21kg/㎡ and 40kg/㎡
- Diagnosis of type Ⅱ diabetes before 3 months
- C-peptide level is over 1.0 ng/ml
- Condition for female having contraception methods, surgical sterilization or menopause
- Condition for male agreeing to use of recommendatory and appropriate contraception method
- Agreement with written informed consent
You may not qualify if:
- Type I diabetes, gestational diabetes or secondary diabetes
- Treatment with insulin or thiazolidinediones within 60 days
- Fasting Plasma Glucose level is over 250 mg/dl
- Triglyceride level is 500 mg/dl and over
- Uncontrollable hypertension(Although treat with antihypertension agent, systolic blood pressure greater than 140 mmHg and diastolic blood pressure greater than 90 mmHg)
- History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
- Severe hepatic dysfunction: AST, ALT, Total bilirubin, ALP level over or equal to 2.5 times as high as upper normal limit(UNL)
- Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit
- Anemia for any reason
- Needs treatment for acute disease, uncontrolled other diseae or diabetic complications
- Abnormality of thyroid function(out of normal TSH range )
- History of proliferative diabetic retinopathy
- In treatment concomitant drug having severe risk drug interaction with investigational drug
- History of cancer within 5 years
- History of drug abuse or alcoholism
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The Inje University Busan-Paik Hospital
Busan, South Korea
Soon Chun Hyang University Cheonan Hospital
Cheonan, South Korea
The Hanyang University Medical Center
Gyeonggi-do, South Korea
Wonju Severance Christian Hospital
Kangwon-Do, South Korea
The Hallym University Medical Center
Seoul, South Korea
The Inje University Sanggye-Paik Hospital
Seoul, South Korea
The Korea University Anam Hospital
Seoul, South Korea
The Kyung Hee University Medical Center
Seoul, South Korea
The Seoul National University Bundang Hospital
Seoul, South Korea
Related Publications (1)
Kim SG, Kim DM, Woo JT, Jang HC, Chung CH, Ko KS, Park JH, Park YS, Kim SJ, Choi DS. Efficacy and safety of lobeglitazone monotherapy in patients with type 2 diabetes mellitus over 24-weeks: a multicenter, randomized, double-blind, parallel-group, placebo controlled trial. PLoS One. 2014 Apr 15;9(4):e92843. doi: 10.1371/journal.pone.0092843. eCollection 2014.
PMID: 24736628DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dongseop Choi
The Korea University Anam Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2009
First Posted
October 26, 2009
Study Start
October 1, 2009
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
July 19, 2013
Record last verified: 2013-07