An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus

An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus: A 24-week, Multi Center, Randomized, Double-blind, Parallel-group, Placebo Control, Therapeutic Confirmatory Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: CKD-501 0.5mg; Drug: Placebo

Detailed Description

Diabetes Mellitus is classified into type 1 diabetes and type 2 diabetes mellitus according to the causes of diabetes onset and the treatment of symptoms.

In type 2 diabetes, the combination of insulin resistance and insulin deficiency is working. Diabetes mellitus causing many complications and hospitalization is one of chronic metabolic disorder and diabetes mortality rate has been gradually increasing percentage.

CKD-501 is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It demonstrates that CKD-501 improves even more glycemic and lipid control in comparison to rosiglitazone and pioglitazone.

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 once daily for 24 weeks as a monotherapy in type 2 diabetes mellitus. Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • The Inje University Busan-Paik Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Cheonan Hospital
  • Gyeonggi-do, Korea, Republic of
    • The Hanyang University Medical Center
  • Kangwon-Do, Korea, Republic of
    • Wonju Severance Christian Hospital
  • Seoul, Korea, Republic of
    • The Inje University Sanggye-Paik Hospital
  • Seoul, Korea, Republic of
    • The Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • The Hallym University Medical Center
  • Seoul, Korea, Republic of
    • The Kyung Hee University Medical Center
  • Seoul, Korea, Republic of
    • The Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Hepatitis B Antigen(HBsAg) test is positive
• Treatment systemic or inhalant corticosteroids within 1 month prior to Screening
• Patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
• Fertile women who not practice contraception with appropriate methods
• Pregnant women or nursing mothers
• Has a contraindication to treatment investigational drug from the medical and psychogenic side
• An impossible one who participates in clinical trial by legal or investigator's decision
• Participated in other trial within 4 weeks
• Participating in other trial at present

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Indistinguishable tablet from CKD-501, Orally, 1 tablet once daily for 24 weeks
Experimental: CKD-501 0.5mg	Drug: CKD-501 0.5mg; 0.5 mg/tablet, orally, 1 tablet once daily for 24 weeks or 52 weeks (If extension study); Other Names: Lobeglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Glycosylated Hemoglobin (HbA1c)	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Study Chair: Dongseop Choi, The Korea University Anam Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 23, 2009
• First Submitted That Met QC Criteria: October 23, 2009
• First Posted (Estimate): October 26, 2009

Study Record Updates

• Last Update Posted (Estimate): July 19, 2013
• Last Update Submitted That Met QC Criteria: July 17, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Type II Diabetes; Diabetes Mellitus, Type 2; glitazone; Hypolipidemic; oral hypoglycemic agent
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CKD-19DM09B; 19DM09B