A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Ina… (NCT07379333) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
South Korea118 participantsStarted 2026-04-13
Plain-language summary
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
Who can participate
Age range
19 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Adults aged 19 years or older
* 2\. Diagnosed with type 2 diabetes
* 3\. HbA1c level 7.0% ≤ HbA1c ≤ 10.0%
* 4\. 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
* 5\. 20 kg/m2 ≤ BMI ≤ 45 kg/m2
* 6\. Agree to the recommended exercise and diet regimen during this clinical trial
Exclusion Criteria:
* 1\. Patients with a history of allergy or resistance to the investigational drug or background therapy
* 2\. Patients diagnosed with a type of diabetes other than type 2 diabetes
* 3\. Patients with uncontrolled severe diabetic complications
* 4\. Patients with a history of acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis.
* 5\. Patients with a history of diabetic coma or precoma
* 6\. Those with a history of severe hypoglycemia
* 7\. Those whose weight change \> 5 kg
* 8\. History of gastrointestinal disease or surgery
* 9\. History of bariatric surgery
* 10\. History of gallbladder disease
* 11\. History of a disease that could affect the interpretation of HbA1c
* 12\. History of acute or chronic pancreatitis or pancreatectomy
* 13\. History (including family history) of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN2).
* 14\. Uncontrolled hypertension
* 15\. Severe infections or severe trauma
* 16\. Malnutrition, starvation, or debility, as determined by the investigator.
* 17\. P…