Diabetes Mellitus, Type 2 Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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