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

Phase 3 Completed 173 enrolled Chong Kun Dang Pharmaceutical

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2009-10
Primary completion: 2012-01
Completion: 2012-01

Outcome

Met primary endpoint

paper At 24 weeks, a significant reduction in HbA1c was observed with lobeglitazone versus placebo (-0.44% vs 0.16%, mean difference -0.6%, p<0.0001). PMID 24736628 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lobeglitazone	Small molecule	0.5 mg	Oral