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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorHanmi Pharmaceutical Company Limited

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

Treatment groups

118 Participants
are divided into 2 treatment groups