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

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: HM11260C

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• South Korea
  • Gyeonggi-do, South Korea
    • Recruiting
    • The Catholic University Of Korea Bucheon St. Mary's Hospital
    • Contact: Sung Rae Kim; Email: dream4hope@naver.com
    • Principal Investigator: Sung Rae Kim, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HM11260C; Weekly administration by subcutaneous injection	Drug: HM11260C; Test drug
Placebo Comparator: Placebo; Weekly administration by subcutaneous injection	Drug: Placebo; Placebo drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c at 36 weeks compared to baseline	baseline, 36 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c at Week 24	baseline, 24 weeks
Proportion of subjects achieving HbA1c <7.0% at Weeks 24 and 36	24, 36 weeks
Proportion of subjects achieving HbA1c <6.5% at Weeks 24 and 36	24, 36 weeks
Change from baseline in FPG at Weeks 24 and 36	baseline, 24, 36 weeks
Proportion of subjects receiving rescue medication at Weeks 24 and 36	24, 36 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HM-GLOW-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No