A Phase 4 interventional study of Lobelitazone 0.5mg and Sitagliptin 100mg in Diabetes Mellitus, Type 2, sponsored by Chong Kun Dang Pharmaceutical. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2015-07-08.
Sponsored by Chong Kun Dang Pharmaceutical · Phase 4, Interventional, and Treatment
Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.
Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 248 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Applied to 1 or more categories listed below (NCEP-ATP III)
At visit 1: Applied to 1 or more categories listed below
Exclusion Criteria:
Applied to 1 or more categories listed below
Lobelitazone 0.5mg
Drug: Lobelitazone 0.5mg
Sitagliptin 100mg
Drug: Sitagliptin 100mg
Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
The mean percent change of HbA1c
Time frame: from baseline at 24 weeks
The rate of Metabolic Syndrome
Time frame: from baseline at 24 weeks
The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)
Time frame: from baseline at 24 weeks
The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI)
Time frame: from baseline at 24 weeks
The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B)
Time frame: from baseline at 24 weeks
The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)
Time frame: from baseline at 24 weeks
The mean percent change of Adiponectin
Time frame: from baseline at 24 weeks
The mean percent change of hs-CRP
Time frame: from baseline at 24 weeks
Safety evaluation - physical examination, vital sign, laboratory, adverse event
Time frame: from baseline at 24 weeks
This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Chong Kun Dang Pharmaceutical