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

NCT07379333 | Not Yet Recruiting Phase 3

• 1 other identifier: HM-GLOW-301
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c at 36 weeks compared to baseline

  baseline, 36 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

HM11260C

EXPERIMENTAL

Weekly administration by subcutaneous injection

Drug: HM11260C

Placebo

PLACEBO COMPARATOR

Weekly administration by subcutaneous injection

Drug: Placebo

Interventions

HM11260C DRUG

Test drug

HM11260C

Placebo DRUG

Placebo drug

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adults aged 19 years or older
• \. Diagnosed with type 2 diabetes
• \. HbA1c level 7.0% ≤ HbA1c ≤ 10.0%
• \. 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
• \. 20 kg/m2 ≤ BMI ≤ 45 kg/m2
• \. Agree to the recommended exercise and diet regimen during this clinical trial

You may not qualify if:

• \. Patients with a history of allergy or resistance to the investigational drug or background therapy
• \. Patients diagnosed with a type of diabetes other than type 2 diabetes
• \. Patients with uncontrolled severe diabetic complications
• \. Patients with a history of acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis.
• \. Patients with a history of diabetic coma or precoma
• \. Those with a history of severe hypoglycemia
• \. Those whose weight change \> 5 kg
• \. History of gastrointestinal disease or surgery
• \. History of bariatric surgery
• \. History of gallbladder disease
• \. History of a disease that could affect the interpretation of HbA1c
• \. History of acute or chronic pancreatitis or pancreatectomy
• \. History (including family history) of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN2).
• \. Uncontrolled hypertension
• \. Severe infections or severe trauma

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

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

Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jee Won Shon

CONTACT

82-2-410-9037; jeewon.shon@hanmi.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

KR (1)