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NCT07379333RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 13 May 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
118 (estimated)
First submitted
23 Jan 2026
Start date
13 Apr 2026
Primary completion date
Nov 2027
Lead sponsor
Hanmi Pharmaceutical Company Limited
NCT number
NCT07379333

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 118
  • From 13 Apr 2026 to the primary completion date, Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 1\. Patients with a history of allergy or resistance to the investigational drug or background therapy
  • 26\. Those who have participated in another clinical trial and received investigational drugs within 30 days

Other illness

  • 2\. Patients diagnosed with a type of diabetes other than type 2 diabetes
  • 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
  • 8\. History of gastrointestinal disease or surgery
  • 9\. History of bariatric surgery
  • 10\. History of gallbladder disease
  • 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
  • 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
  • 24\. Patients with moderate or severe renal impairment
  • 25\. History of Diabetic medications or weight-loss medications

Lab values

  • 11\. History of a disease that could affect the interpretation of HbA1c
  • 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

Other

  • 3\. Patients with uncontrolled severe diabetic complications
  • 7\. Those whose weight change \> 5 kg
  • 16\. Malnutrition, starvation, or debility, as determined by the investigator.
  • 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.

Who the study is looking for

  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The Catholic University of Korea Bucheon St. Mary's Hospital
Coordinator of this site? Confirm its status
Gyeonggi-doSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.