HM11260C added to metformin and dapagliflozin for adults with type 2 diabetes
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
We will test whether adding HM11260C helps adults with type 2 diabetes whose blood sugar isn't controlled on metformin and dapagliflozin.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hanmi Pharmaceutical Company Limited Industry-sponsored |
| Locations | 1 site (Gyeonggi-do) |
| Trial ID | NCT07379333 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 19 or older with type 2 diabetes, HbA1c 7.0–10.0%, BMI 20–45 kg/m2, and on a stable regimen of metformin (≥1,000 mg/day) plus dapagliflozin 10 mg/day for at least 8 weeks who agree to recommended diet and exercise are ideal candidates.
Not a fit: Patients with other types of diabetes, uncontrolled severe diabetic complications, a history of lactic acidosis or diabetic ketoacidosis, severe hypoglycemia, recent weight change >5 kg, or certain gastrointestinal diseases are unlikely to benefit or may be excluded for safety reasons.
Why it matters
Potential benefit: If effective, HM11260C could help lower HbA1c and improve blood-sugar control for people not adequately controlled on metformin plus dapagliflozin.
How similar studies have performed: Other phase 3 add-on drug trials in type 2 diabetes have shown improved HbA1c when added to metformin and SGLT2 inhibitors, but published phase 3 data specific to HM11260C are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gyeonggi-do
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.