Actively Recruiting
A Phase 3 Randomized, Double-Blind Study Comparing HL1113R1 or HL1113R2 Monotherapy Versus HL1113 Fixed Dose Combination in Patients with Essential Hypertension and Type 2 Diabetes Mellitus
Led by Hanlim Pharm. Co., Ltd. · Updated on 2026-04-27
228
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female subjects aged 19 years or older at the time of written informed consent
- Diagnosed with essential hypertension accompanied by type 2 diabetes mellitus
- etc.
You will not qualify if you...
- Blood pressure measured in the selected arm at both screening and randomization with diastolic blood pressure ≥ 110 mmHg
- Blood pressure measured three consecutive times in each arm at screening shows a difference of ≥ 20 mmHg systolic and ≥ 10 mmHg diastolic
- etc.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive HL1113R1 or HL1113R2 monotherapy or HL1113 fixed dose combination once daily for hypertension and type 2 diabetes management.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
The Catholic University of Korea Bucheon St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
Research Team
K
Kang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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