Type 2 DiabetesPhase 3NCT07379333
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
A Phase 3 study testing HM11260C in people with Type 2 Diabetes, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HM11260C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Apr 2026to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea Bucheon St. Mary's Hospital
Gyeonggi-do
Sung Rae Kim, dream4hope@naver.com
Sung Rae Kim, PhD
About this study
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
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
- Being tested
- HM11260C, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM11260CDrug
Test drug
PlaceboDrug
Placebo drug
| Study group | Role | What they receive |
|---|---|---|
| HM11260C | Experimental | Weekly administration by subcutaneous injection Receives: Drug: HM11260C |
| Placebo | Placebo comparator | Weekly administration by subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c at 36 weeks compared to baseline
Measured: baseline, 36 weeks
Secondary outcomes (5)
Change from baseline in HbA1c at Week 24
Measured: baseline, 24 weeks
Proportion of subjects achieving HbA1c <7.0% at Weeks 24 and 36
Measured: 24, 36 weeks
Proportion of subjects achieving HbA1c <6.5% at Weeks 24 and 36
Measured: 24, 36 weeks
Change from baseline in FPG at Weeks 24 and 36
Measured: baseline, 24, 36 weeks
Proportion of subjects receiving rescue medication at Weeks 24 and 36
Measured: 24, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start13 Apr 2026
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379333
- Sponsor's protocol ID
- HM-GLOW-301
- Status last verified
- May 2026
- First submitted
- 23 Jan 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07379333
- Acronym / sponsor ID
- HM-GLOW-301
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HM11260C | Experimental | Drug: HM11260CWeekly administration by subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboWeekly administration by subcutaneous injection |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM11260CTest drug | Drug | HM11260C |
| PlaceboPlacebo drug | Drug | Placebo |
Primary outcome
Change in HbA1c at 36 weeks compared to baseline
Time frame: baseline, 36 weeks
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HM11260C in people with Type 2 Diabetes, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jee Won Shon (82-2-410-9037, jeewon.shon@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c at 36 weeks compared to baseline (time frame: baseline, 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.