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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01001611
First received: October 23, 2009
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: CKD-501 0.5mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in HbA1c target achievement rate (HbA1c<7%) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse event and so on [ Time Frame: 24 weeks or 52 weeks ] [ Designated as safety issue: Yes ]
  • 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)) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: October 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lobeglitazone
Placebo Comparator: Placebo Drug: Placebo
Indistinguishable tablet from CKD-501, Orally, 1 tablet once daily for 24 weeks
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001611

Locations
Korea, Republic of
The Inje University Busan-Paik Hospital
Busan, Korea, Republic of
Soon Chun Hyang University Cheonan Hospital
Cheonan, Korea, Republic of
The Hanyang University Medical Center
Gyeonggi-do, Korea, Republic of
Wonju Severance Christian Hospital
Kangwon-Do, Korea, Republic of
The Hallym University Medical Center
Seoul, Korea, Republic of
The Seoul National University Bundang Hospital
Seoul, Korea, Republic of
The Kyung Hee University Medical Center
Seoul, Korea, Republic of
The Inje University Sanggye-Paik Hospital
Seoul, Korea, Republic of
The Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Study Chair: Dongseop Choi The Korea University Anam Hospital
  More Information

No publications provided by Chong Kun Dang Pharmaceutical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01001611     History of Changes
Other Study ID Numbers: CKD-19DM09B, 19DM09B
Study First Received: October 23, 2009
Last Updated: July 17, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Diabetes Mellitus, Type 2
glitazone
Type II Diabetes
Hypolipidemic
oral hypoglycemic agent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014