Clinical trial NCT01001611: An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
glitazone
Type II Diabetes
Hypolipidemic
oral hypoglycemic agent
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change from baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in HbA1c target achievement rate (HbA1c<7%)
timeFrame: 24 weeks
measure: 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)
timeFrame: 24 weeks
measure: Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse event and so on
timeFrame: 24 weeks or 52 weeks
measure: 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))
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: The Inje University Busan-Paik Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Hanyang University Medical Center
city: Kangwon-Do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Seoul
country: Korea, Republic of
facility: The Hallym University Medical Center
city: Seoul
country: Korea, Republic of
facility: The Inje University Sanggye-Paik Hospital
city: Seoul
country: Korea, Republic of
facility: The Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: The Seoul National University Bundang Hospital
Study officials:
affiliation: The Korea University Anam Hospital
name: Dongseop Choi
role: STUDY_CHAIR
References:
citation: 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.