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NCT Number: NCT07379333

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Gyeonggi-do, South Korea

Location status: Recruiting

Location contact

Sung Rae Kim

CONTACT

[email protected]

Sung Rae Kim, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HM11260C

Drug

Test drug

Placebo

Drug

Placebo drug

Primary outcomes

  1. Change in HbA1c at 36 weeks compared to baseline

    Time frame: baseline, 36 weeks

Secondary outcomes

  1. Change from baseline in HbA1c at Week 24

    Time frame: baseline, 24 weeks

  2. Proportion of subjects achieving HbA1c <7.0% at Weeks 24 and 36

    Time frame: 24, 36 weeks

  3. Proportion of subjects achieving HbA1c <6.5% at Weeks 24 and 36

    Time frame: 24, 36 weeks

  4. Change from baseline in FPG at Weeks 24 and 36

    Time frame: baseline, 24, 36 weeks

  5. Proportion of subjects receiving rescue medication at Weeks 24 and 36

    Time frame: 24, 36 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Jee Won Shon

CONTACT

[email protected]

82-2-410-9037

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 30, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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