Skip to content
TrialMatch
Sign up
Recruiting Phase 3

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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

Condition
Type 2 Diabetes
Tested
HM11260C, Placebo
Sponsor
Hanmi Pharmaceutical Company Limited

Who can join

Age
19 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 19 years
  • Study condition: Type 2 Diabetes
  • 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 29

  • 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

1 site, 1 recruiting

The Catholic University of Korea Bucheon St. Mary's Hospital

Gyeonggi-do, South Korea

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.