Overview

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

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.