Menu
Recruiting NCT07379333

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

Phase III Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HM11260C, Placebo.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug HM11260C
    Test drug
  • Drug Placebo
    Placebo drug

Primary outcome measures

  • Change in HbA1c at 36 weeks compared to baseline [Time frame: baseline, 36 weeks]
Secondary outcome measures (5)
  • Change from baseline in HbA1c at Week 24 [Time frame: baseline, 24 weeks]
  • Proportion of subjects achieving HbA1c <7.0% at Weeks 24 and 36 [Time frame: 24, 36 weeks]
  • Proportion of subjects achieving HbA1c <6.5% at Weeks 24 and 36 [Time frame: 24, 36 weeks]
  • Change from baseline in FPG at Weeks 24 and 36 [Time frame: baseline, 24, 36 weeks]
  • Proportion of subjects receiving rescue medication at Weeks 24 and 36 [Time frame: 24, 36 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • The Catholic University of Korea Bucheon St. Mary's Hospital — Gyeonggi-do

Identifiers

NCT: NCT07379333 · HM-GLOW-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗