Type 2 DiabetesPhase 3UNIGUIDE-1NCT07659574
Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone（UNIGUIDE-1）
A Phase 3 study testing UBT251 Injection 2.0 mg, UBT251 Injection 4.0 mg and UBT251 Injection 6.0 mg in people with Type 2 Diabetes, run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.
Trial summary
This multicenter, randomized, double-Blind, parallel-group, placebo-controlled phase III trial is to evaluate the efficacy and safety of UBT251 Injection in patients with Type 2 Diabetes Mellitus with inadequate glycemic control on diet and exercise alone Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- UBT251 Injection 2.0 mg, UBT251 Injection 4.0 mg and UBT251 Injection 6.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2026to 22 Oct 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of gender;
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months in accordance with the 2019 World Health Organization (WHO) criteria;
- Managed solely through diet and exercise intervention (without the use of any glucose-lowering medications) for at least 3 months prior to screening;
- Glycated hemoglobin (HbA1c) level ≥7.5% and ≤10.5% at screening;
- Body mass index (BMI) ≥23.0 kg/m² at screening, and stable body weight (change <5%, which may be based on the participant's self-report) within 3 months prior to screening;
- Trial participants (including their partners) have no plan for pregnancy from screening to 6 months after trial completion, and are willing to comply with the contraceptive measures specified in the trial, and have no plan for sperm or egg donation within 6 months after trial completion;
- Have been fully informed about this study and voluntarily sign a written informed consent form.
Who cannot join
- Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;
- History of medication use within 3 months prior to screening that meets any of the following conditions:
- 1) Use of any glucose-lowering medications, including glucagon-like peptide-1 (GLP-1) analogues, oral antidiabetic drugs (OADs) (including but not limited to metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, glinides, sodium-glucose cotransporter 2 (SGLT-2) inhibitors), insulin (except for short-term use ≤14 days for acute conditions, such as perioperative or inpatient use), traditional Chinese medicines, or health supplements with glucose-lowering effects; 2) Use of medications that may affect glucose metabolism, such as systemic glucocorticoids, growth hormone, etc. (except for cumulative use <7 days with the last dose administered more than 7 half-lives prior to the first day of screening); 3) Use of weight-loss medications (including but not limited to orlistat, liraglutide, or other similar prescription or over-the-counter medications for weight loss); 3.History or evidence of any of the following diseases:
- Diagnosis of other types of diabetes: such as type 1 diabetes mellitus (T1DM), other specific types of diabetes (e.g., genetic defects in beta-cell function, genetic defects in insulin action, diseases of the exocrine pancreas, etc.);
- History of acute or chronic pancreatitis, or pancreatic surgery;
- History of symptomatic gallbladder disease within 1 year before screening (excluding trial participants who have undergone cholecystectomy [completed at least 3 months before screening] without long-term complications), or abdominal ultrasound at screening indicating large gallstones (diameter ≥2 cm), gallbladder polyps (diameter ≥1 cm), or other gallbladder lesions that the study physician determines may affect trial participant safety;
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- Personal or family history (within first-degree relatives, i.e., parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
- History of hematological disorders that may affect HbA1c test results or increase the risk to trial participants (e.g., aplastic anemia, myelodysplastic syndromes, etc.), or any diseases causing hemolysis or erythrocyte instability (e.g., sickle cell disease, thalassemia, etc.);
- History of moderate to severe depression or severe psychiatric disorders (including but not limited to suicidal ideation or attempt, schizophrenia, bipolar disorder, etc.);
- History of clinically significant cardiovascular or cerebrovascular disease within 6 months before screening
- Severe retinal or macular disease (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.) at screening or in the past, requiring urgent treatment as determined by the study physician;
- Severe hypoglycemia (hypoglycemia accompanied by severe cognitive impairment requiring assistance from others to recover) or recurrent symptomatic hypoglycemia (≥2 episodes in 6 months) within 6 months prior to screening;
- History of acute metabolic complications of diabetes (including but not limited to diabetic ketoacidosis [DKA], hyperosmolar hyperglycemic state [HHS] requiring hospitalization, hyperosmolar coma, lactic acidosis, etc.) or diabetic foot within 6 months prior to screening;
- History of malignancy; 4.Blood loss ≥400 mL (including trauma, blood draw, blood donation) within 3 months before screening, or receipt of blood or blood component transfusion; 5.Lactating women or pregnant women;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Zhiguang Zhou, 0731 8529 5999
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Trial to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone（UNIGUIDE-1）
This multicenter, randomized, double-Blind, parallel-group, placebo-controlled phase III trial is to evaluate the efficacy and safety of UBT251 Injection in patients with Type 2 Diabetes Mellitus with inadequate glycemic control on diet and exercise alone
- Conditions
- Type 2 Diabetes
- Being tested
- UBT251 Injection 2.0 mg, UBT251 Injection 4.0 mg, UBT251 Injection 6.0 mg, UBT251 Injection Placebo 2.0 mg, UBT251 Injection Placebo 4.0 mg
- 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.
UBT251 Injection 2.0 mgDrug
UBT251 Injection subcutaneously once weekly
UBT251 Injection 4.0 mgDrug
UBT251 Injection subcutaneously once weekly
UBT251 Injection 6.0 mgDrug
UBT251 Injection subcutaneously once weekly
UBT251 Injection Placebo 2.0 mgDrug
UBT251 Injection placebo subcutaneously once weekly
UBT251 Injection Placebo 4.0 mgDrug
UBT251 Injection placebo subcutaneously once weekly
UBT251 Injection Placebo 6.0 mgDrug
UBT251 Injection placebo subcutaneously once weekly
| Study group | Role | What they receive |
|---|---|---|
| UBT251 Injection 2.0 mg | Experimental | Each subject will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. Receives: Drug: UBT251 Injection 2.0 mg |
| UBT251 Injection 4.0 mg | Experimental | Each subject will receive UBT251 Injection, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. Receives: Drug: UBT251 Injection 4.0 mg |
| UBT251 Injection 6.0 mg | Experimental | Each subject will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. Receives: Drug: UBT251 Injection 6.0 mg |
| UBT251 Injection Placebo 2.0 mg | Placebo comparator | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 40 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 40 weeks.In the 12-week extension phase, subjects were administered UBT251 injection as an additional treatment. Receives: Drug: UBT251 Injection Placebo 2.0 mg |
| UBT251 Injection Placebo 4.0 mg | Placebo comparator | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 40 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 40 weeks.In the 12-week extension phase, subjects were administered UBT251 injection as an additional treatment. Receives: Drug: UBT251 Injection Placebo 4.0 mg |
| UBT251 Injection Placebo 6.0 mg | Placebo comparator | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 40 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 40 weeks.In the 12-week extension phase, subjects were administered UBT251 injection as an additional treatment. Receives: Drug: UBT251 Injection Placebo 6.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c from Baseline
Measured: Week 40
Secondary outcomes (5)
Proportion of participants with HbA1c <7.0%
Proportion of participants with HbA1c <7.0% from baseline
Measured: Week 40
Body weight
Percent change in body weight from baseline
Measured: Week 40
Proportion of participants with body weight reduction ≥5%
Proportion of participants with body weight reduction ≥5% from baseline
Measured: Week 40
Proportion of trial participants with HbA1c <7.0% and body weight reduction ≥5%
Proportion of trial participants with HbA1c <7.0% and body weight reduction ≥5% from baseline
Measured: Week 40
HbA1c
Change in HbA1c from baseline
Measured: Week 12，Week 24，Week 32，Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start7 Sep 2026
- Primary completion24 Sep 2027 (estimated)
- Study completion22 Oct 2027 (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 The United Bio-Technology (Hengqin) Co., Ltd.The 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659574
- Sponsor's protocol ID
- TUL-UBT251（III-2）202602
- Acronym
- UNIGUIDE-1
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Trial to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone（UNIGUIDE-1）
- ClinicalTrials.gov ID
- NCT07659574
- Acronym / sponsor ID
- UNIGUIDE-1 / TUL-UBT251（III-2）202602
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- 24 Sep 2027 (estimated)
- Study completion
- 22 Oct 2027 (estimated)
- First posted
- 22 Jun 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.
This multicenter, randomized, double-Blind, parallel-group, placebo-controlled phase III trial is to evaluate the efficacy and safety of UBT251 Injection in patients with Type 2 Diabetes Mellitus with inadequate glycemic control on diet and exercise alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| UBT251 Injection 2.0 mg | Experimental | Drug: UBT251 Injection 2.0 mgEach subject will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Injection 4.0 mg | Experimental | Drug: UBT251 Injection 4.0 mgEach subject will receive UBT251 Injection, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Injection 6.0 mg | Experimental | Drug: UBT251 Injection 6.0 mgEach subject will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Injection Placebo 2.0 mg | Placebo comparator | Drug: UBT251 Injection Placebo 2.0 mgEach subject will receive UBT251 Injection Placebo, s.c. once weekly for 40 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 40 weeks.In the 12-week extension phase, subjects were administered UBT251 injection as an additional treatment. |
| UBT251 Injection Placebo 4.0 mg | Placebo comparator | Drug: UBT251 Injection Placebo 4.0 mgEach subject will receive UBT251 Injection Placebo, s.c. once weekly for 40 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 40 weeks.In the 12-week extension phase, subjects were administered UBT251 injection as an additional treatment. |
| UBT251 Injection Placebo 6.0 mg | Placebo comparator | Drug: UBT251 Injection Placebo 6.0 mgEach subject will receive UBT251 Injection Placebo, s.c. once weekly for 40 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 40 weeks.In the 12-week extension phase, subjects were administered UBT251 injection as an additional treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of gender;
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months in accordance with the 2019 World Health Organization (WHO) criteria;
- Managed solely through diet and exercise intervention (without the use of any glucose-lowering medications) for at least 3 months prior to screening;
- Glycated hemoglobin (HbA1c) level ≥7.5% and ≤10.5% at screening;
- Body mass index (BMI) ≥23.0 kg/m² at screening, and stable body weight (change <5%, which may be based on the participant's self-report) within 3 months prior to screening;
Key exclusion criteria (14 listed)
- Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;
- History of medication use within 3 months prior to screening that meets any of the following conditions:
- 1) Use of any glucose-lowering medications, including glucagon-like peptide-1 (GLP-1) analogues, oral antidiabetic drugs (OADs) (including but not limited to metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, glinides, sodium-glucose cotransporter 2 (SGLT-2) inhibitors), insulin (except for short-term use ≤14 days for acute conditions, such as perioperative or inpatient use), traditional Chinese medicines, or health supplements with glucose-lowering effects; 2) Use of medications that may affect glucose metabolism, such as systemic glucocorticoids, growth hormone, etc. (except for cumulative use <7 days with the last dose administered more than 7 half-lives prior to the first day of screening); 3) Use of weight-loss medications (including but not limited to orlistat, liraglutide, or other similar prescription or over-the-counter medications for weight loss); 3.History or evidence of any of the following diseases:
- Diagnosis of other types of diabetes: such as type 1 diabetes mellitus (T1DM), other specific types of diabetes (e.g., genetic defects in beta-cell function, genetic defects in insulin action, diseases of the exocrine pancreas, etc.);
- History of acute or chronic pancreatitis, or pancreatic surgery;
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 |
|---|---|---|
| UBT251 Injection 2.0 mgUBT251 Injection subcutaneously once weekly | Drug | UBT251 Injection 2.0 mg |
| UBT251 Injection 4.0 mgUBT251 Injection subcutaneously once weekly | Drug | UBT251 Injection 4.0 mg |
| UBT251 Injection 6.0 mgUBT251 Injection subcutaneously once weekly | Drug | UBT251 Injection 6.0 mg |
| UBT251 Injection Placebo 2.0 mgUBT251 Injection placebo subcutaneously once weekly | Drug | UBT251 Injection Placebo 2.0 mg |
| UBT251 Injection Placebo 4.0 mgUBT251 Injection placebo subcutaneously once weekly | Drug | UBT251 Injection Placebo 4.0 mg |
| UBT251 Injection Placebo 6.0 mgUBT251 Injection placebo subcutaneously once weekly | Drug | UBT251 Injection Placebo 6.0 mg |
Primary outcome
HbA1c
Time frame: Week 40
Change in HbA1c from Baseline
5 secondary outcomes
Proportion of participants with HbA1c <7.0%
Time frame: Week 40
Body weight
Time frame: Week 40
Proportion of participants with body weight reduction ≥5%
Time frame: Week 40
Proportion of trial participants with HbA1c <7.0% and body weight reduction ≥5%
Time frame: Week 40
HbA1c
Time frame: Week 12，Week 24，Week 32，Week 52
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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 UBT251 Injection 2.0 mg, UBT251 Injection 4.0 mg and UBT251 Injection 6.0 mg in people with Type 2 Diabetes, run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.
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 7 inclusion and 14 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 15 Sep 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 China. 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 Haiyan Zhang (+86 18998165570, zhanghy@tul.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Week 40). 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 15 Sep 2026.