About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HM11260C
- Placebo