HM11260C added to metformin and dapagliflozin for adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind phase 3 trial comparing HM11260C to placebo in adults with type 2 diabetes who remain above target glucose levels despite stable metformin and dapagliflozin therapy. Eligible participants have HbA1c between 7.0% and 10.0%, BMI 20–45 kg/m2, and must have been on metformin ≥1,000 mg/day plus dapagliflozin 10 mg/day for at least 8 weeks. Participants are randomized to receive HM11260C or placebo in addition to their background medications, with efficacy and safety monitored during the treatment period. Primary outcomes focus on change in HbA1c and safety measures including hypoglycemia, metabolic acidosis, and gastrointestinal adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Catholic University of Korea Bucheon St. Mary's Hospital
  Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Jee Won Shon
• Email: jeewon.shon@hanmi.co.kr
• Phone: 82-2-410-9037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.