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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
173
0.5 mg/tablet, orally, 1 tablet once daily for 24 weeks or 52 weeks (If extension study)
Indistinguishable tablet from CKD-501, Orally, 1 tablet once daily for 24 weeks
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
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: 24 weeks
Change from baseline in HbA1c target achievement rate (HbA1c<7%)
Time frame: 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)
Time frame: 24 weeks
Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse event and so on
Time frame: 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))
Time frame: 24 weeks
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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