Actively Recruiting
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Led by Hanmi Pharmaceutical Company Limited · Updated on 2026-05-13
118
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in patients with type 2 diabetes mellitus inadequately controlled with metformin and dapagliflozin
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Diagnosed with type 2 diabetes
- HbA1c level 7.0% HbA1c 10.0%
- Stable administration of metformin ( 1,000 mg/day) and dapagliflozin (10 mg/day) without any change in dosage or formulation for at least 8 weeks prior to Visit 1
- Body mass index (BMI) between 20 kg/m2 and 45 kg/m2
- Agree to follow the recommended exercise and diet regimen during this clinical trial
You will not qualify if you...
- History of allergy or resistance to the investigational drug or background therapy
- Diagnosis of a type of diabetes other than type 2 diabetes
- Uncontrolled severe diabetic complications
- History of acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis
- History of diabetic coma or precoma
- History of severe hypoglycemia
- Weight change greater than 5 kg
- History of gastrointestinal disease or surgery
- History of bariatric surgery
- History of gallbladder disease
- History of a disease that could affect the interpretation of HbA1c
- History of acute or chronic pancreatitis or pancreatectomy
- History or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN2)
- Uncontrolled hypertension
- Severe infections or severe trauma
- Malnutrition, starvation, or debility as determined by the investigator
- Pituitary or adrenal insufficiency
- Tissue hypoxia, such as respiratory failure or shock
- History of alcoholism or drug abuse
- History of malignant tumors
- Heart failure, ischemic heart disease, severe cerebrovascular disease, or transient ischemic attack (TIA)
- Amylase or lipase levels greater than 3 times the upper limit of normal (ULN) or fasting plasma glucose (FPG) greater than 270 mg/dL
- Severe hepatic impairment or AST or ALT levels greater than 3 times ULN or total bilirubin greater than 1.5 times ULN
- Moderate or severe renal impairment
- History of diabetic medications or weight-loss medications
- Participation in another clinical trial and receipt of investigational drugs within 30 days
- Pregnant or lactating women, or women of childbearing potential
- Women of childbearing potential and men who do not consent to the use of specified contraceptive methods
- Any other condition considered by the investigator as not appropriate for participation in the clinical study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Catholic University of Korea Bucheon St. Mary's Hospital
Gyeonggi-do, South Korea
Actively Recruiting
Research Team
J
Jee Won Shon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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