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A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin

NCT07379333 · Hanmi Pharmaceutical Company Limited
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Official title
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
About this study
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
Eligibility criteria
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\. Pituitary or adrenal insufficiency. * 18\. Tissue hypoxia, such as respiratory failure or shock. * 19\. History of alcoholism or drug abuse * 20\. History of malignant tumors * 21\. Heart failure, Ischemic heart disease, Severe cerebrovascular disease, TIA * 22\. Patients with one of the following clinical laboratory test results : Amylase or Lipase \> 3 X ULN / FPG \> 270 mg/dL * 23\. Patients with severe hepatic impairment or one of the following laboratory test results : AST or ALT \> 3 X ULN / Total bilirubin \> 1.5 X ULN * 24\. Patients with moderate or severe renal impairment * 25\. History of Diabetic medications or weight-loss medications * 26\. Those who have participated in another clinical trial and received investigational drugs within 30 days * 27\. Pregnant or lactating women, or women of childbearing potential * 28\. Women of childbearing potential and men who do not consent to the use of the following contraceptive methods * 29\. Considered by investigator as not appropriate to participate in the clinical study with other reason.
Study design
Enrollment target: 118 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-04-13
Estimated completion: 2028-01
Last updated: 2026-05-13
Interventions
Drug: HM11260CDrug: Placebo
Primary outcomes
  • Change in HbA1c at 36 weeks compared to baseline (baseline, 36 weeks)
Sponsor
Hanmi Pharmaceutical Company Limited · industry
Contacts & investigators
ContactJee Won Shon · contact · jeewon.shon@hanmi.co.kr · 82-2-410-9037
All locations (1)
The Catholic University of Korea Bucheon St. Mary's HospitalRecruiting
Gyeonggi-do, South Korea
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin · TrialPath