NCT01001611

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	CKD-501 0.5mg	0.5 mg/tablet, orally, 1 tablet once daily for 24 weeks or 52 weeks (If extension study)
DRUG	Placebo	Indistinguishable tablet from CKD-501, Orally, 1 tablet once daily for 24 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2009-10-26
• Last updated: 2013-07-19

Locations

9 sites across 1 country: South Korea