Phase 3 Study Comparing HL1113R1 or HL1113R2 Monotherapy to HL1113 Fixed Dose Combination in Adults with Essential Hypertension and Type 2 Diabetes

What this Trial Is About

Researchers are conducting a phase 3 randomized, active controlled, double-blind study to assess the efficacy and safety of HL1113R1 or HL1113R2 monotherapy compared to a fixed dose combination of HL1113 in adults with essential hypertension and type 2 diabetes mellitus. This trial evaluates how these treatments affect blood pressure and blood sugar control in patients managing both conditions together. Participants are randomly assigned to one of four groups receiving daily oral treatments for 12 weeks the test group gets HL1113T2 plus a placebo the exploratory test group receives HL1113T1 plus placebo control group 1 receives HL1113R1 plus placebo and control group 2 receives HL1113R2 plus placebo. All treatments are given once daily, and the study is conducted across multiple centers with quadruple masking to ensure unbiased results. During the 12-week treatment period, researchers will measure changes from baseline in mean seated systolic blood pressure and HbA1c levels at week 12 to compare the different therapies. Participants will undergo regular assessments to monitor blood pressure and blood sugar, with safety and treatment adherence carefully tracked throughout. The study is sponsored by Hanlim Pharm. Co., Ltd. and is expected to continue until December 2028.

Clinical Trial to Evaluate the Efficacy and Safety of Monotherapy Group of HL1113R1 or HL1113R2 Versus HL1113 (Fixed Dose Combination) in Patients With Essential Hypertension and Type II Diabetes Mellitus