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

Hanmi Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: HM11260C; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07379333

HM-GLOW-301

Details and patient eligibility

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

Enrollment: 118 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 2 patient groups, including a placebo group

HM11260C

Experimental group

Description:

Weekly administration by subcutaneous injection

Treatment:

Drug: HM11260C

Placebo

Placebo Comparator group

Description:

Weekly administration by subcutaneous injection

Treatment:

Drug: Placebo