Type 2 DiabetesPhase 1/2TREDNCT07374328
Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus
A Phase 1/2 study testing Semaglutide (1 Mg Dose) and Sitagliptin (DPP4 inhibitor) in people with Type 2 Diabetes, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study is a multicenter, randomized, controlled study. A sample size of 240 cases is proposed to be included. The inclusion criteria are: (1) patients with newly diagnosed type 2 diabetes; (2) age between 18 and 65 years old; (3) HbA1c ≥ 9.0%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Semaglutide (1 Mg Dose) and Sitagliptin (DPP4 inhibitor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Aug 2026
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed type 2 diabetes.
- Age between 18 and 65 years old.
- HbA1c ≥ 9.0%.
Who cannot join
- Type 1 diabetes.
- Elevated creatinine or urinary albumin/creatinine.
- Combined with coronary heart disease, tumor or pregnancy.
- Receiving glucocorticoids.
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 Affiliated Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510260
Wangen Li, Dr, 86-20-34152032, liwg660@126.com
About this study
Official title: Comparison Of Two Triple Hypoglycemic Regimens In Achieving Glycemic Control And Diabetes Remission In Hospitalized Patients With Newly Diagnosed Type 2 Diabetes Mellitus: A Multicenter, Randomized, Clinical Study
This study is a multicenter, randomized, controlled study. A sample size of 240 cases is proposed to be included. The inclusion criteria are: (1) patients with newly diagnosed type 2 diabetes; (2) age between 18 and 65 years old; (3) HbA1c ≥ 9.0%. The exclusion criteria include: (1) type 1 diabetes; (2) elevated creatinine or urinary albumin/creatinine; (3) combined with coronary heart disease, tumor or pregnancy; (4) receiving glucocorticoids. The selected participants are randomly divided into two groups: one group is the semaglutide group, and the other isthe oral medication group. The treatment plan is as follows. Semaglutide group: 0.25 mg per week in the first month, 0.5 mg per week in the second month, and 1.0mg per week from the 3rd to the 8th month of semaglutide. Oral medication group: Sitagliptin 0.1g per day. Both groups were simultaneously treated with metformin (1.0g daily, divided into two doses) and empagliflozin (10mg daily). The first phase of the study was as follows: Semaglutide group: Treatment was initiated until 6 months after the titration dose of 1mg was reached; Oral medication group: Initiate treatment until 6 months after reaching a fixed dose. At the end of the first stage of the study, for the selected participants with HbA1c<6.5%, the hypoglycemic drugs were discontinued and they entered the second stage of the study. The study was concluded after a 3-month follow-up. The evaluation indicators include: effectiveness indicators (HbA1c, diabetes remission rate, continuous glucose monitoring), safety indicators (hypoglycemia, adverse reactions, etc.).
- Conditions
- Type 2 Diabetes
- Being tested
- Semaglutide (1 Mg Dose), Sitagliptin (DPP4 inhibitor)
- Keywords
- triple regimen, diabetes, remission
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (1 Mg Dose)Drug
0.25 mg per week in the first month, 0.5 mg per week in the second month, and 1.0mg of semaglutide per week from the 3rd to the 8th month.
Sitagliptin (DPP4 inhibitor)Drug
Sitagliptin 0.1g per day.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide group: patients receive semaglutide treatment. | Experimental | Patients receive 0.25 mg per week in the first month, 0.5 mg per week in the second month, and 1.0mg of semaglutide per week from the 3rd to the 8th month. Receives: Drug: Semaglutide (1 Mg Dose) |
| Oral medication group: patients receive triple hypoglycemic oral medications. | Active comparator | Patients in oral medication group received sitagliptin 0.1g per day. Both groups were simultaneously treated with metformin (1.0g daily, divided into two doses) and empagliflozin (10mg daily). Receives: Drug: Sitagliptin (DPP4 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes remission rate
Measured: From enrollment to the end of follow-up at 11 months
Secondary outcomes (3)
HbA1c
Measured: From enrollment to the end of follow-up at 11 months
Hypoglycemia rate
Measured: From enrollment to the end of follow-up at 11 months
Adverse reactions
Measured: From enrollment to the end of follow-up at 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jun 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Aug 2026 (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 Second Affiliated Hospital of Guangzhou Medical UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374328
- Sponsor's protocol ID
- TRED
- Acronym
- TRED
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 28 Jan 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Two Triple Hypoglycemic Regimens In Achieving Glycemic Control And Diabetes Remission In Hospitalized Patients With Newly Diagnosed Type 2 Diabetes Mellitus: A Multicenter, Randomized, Clinical Study
- ClinicalTrials.gov ID
- NCT07374328
- Acronym / sponsor ID
- TRED / TRED
- Conditions
- Type 2 Diabetes
- Keywords
- triple regimen, diabetes, remission
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 28 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.
This study is a multicenter, randomized, controlled study. A sample size of 240 cases is proposed to be included. The inclusion criteria are: (1) patients with newly diagnosed type 2 diabetes; (2) age between 18 and 65 years old; (3) HbA1c ≥ 9.0%. The exclusion criteria include: (1) type 1 diabetes; (2) elevated creatinine or urinary albumin/creatinine; (3) combined with coronary heart disease, tumor or pregnancy; (4) receiving glucocorticoids. The selected participants are randomly divided into two groups: one group is the semaglutide group, and the other isthe oral medication group. The treatment plan is as follows. Semaglutide group: 0.25 mg per week in the first month, 0.5 mg per week in the second month, and 1.0mg per week from the 3rd to the 8th month of semaglutide. Oral medication group: Sitagliptin 0.1g per day. Both groups were simultaneously treated with metformin (1.0g daily, divided into two doses) and empagliflozin (10mg daily). The first phase of the study was as follows: Semaglutide group: Treatment was initiated until 6 months after the titration dose of 1mg was reached; Oral medication group: Initiate treatment until 6 months after reaching a fixed dose. At the end of the first stage of the study, for the selected participants with HbA1c<6.5%, the hypoglycemic drugs were discontinued and they entered the second stage of the study. The study was concluded after a 3-month follow-up. The evaluation indicators include: effectiveness indicators (HbA1c, diabetes remission rate, continuous glucose monitoring), safety indicators (hypoglycemia, adverse reactions, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide group: patients receive semaglutide treatment. | Experimental | Drug: Semaglutide (1 Mg Dose)Patients receive 0.25 mg per week in the first month, 0.5 mg per week in the second month, and 1.0mg of semaglutide per week from the 3rd to the 8th month. |
| Oral medication group: patients receive triple hypoglycemic oral medications. | Active comparator | Drug: Sitagliptin (DPP4 inhibitor)Patients in oral medication group received sitagliptin 0.1g per day. Both groups were simultaneously treated with metformin (1.0g daily, divided into two doses) and empagliflozin (10mg daily). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with newly diagnosed type 2 diabetes.
- Age between 18 and 65 years old.
- HbA1c ≥ 9.0%.
Key exclusion criteria (4 listed)
- Type 1 diabetes.
- Elevated creatinine or urinary albumin/creatinine.
- Combined with coronary heart disease, tumor or pregnancy.
- Receiving glucocorticoids.
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 |
|---|---|---|
| Semaglutide (1 Mg Dose)0.25 mg per week in the first month, 0.5 mg per week in the second month, and 1.0mg of semaglutide per week from the 3rd to the 8th month. | Drug | Semaglutide group: patients receive semaglutide treatment. |
| Sitagliptin (DPP4 inhibitor)Sitagliptin 0.1g per day. | Drug | Oral medication group: patients receive triple hypoglycemic oral medications. |
Primary outcome
Diabetes remission rate
Time frame: From enrollment to the end of follow-up at 11 months
3 secondary outcomes
HbA1c
Time frame: From enrollment to the end of follow-up at 11 months
Hypoglycemia rate
Time frame: From enrollment to the end of follow-up at 11 months
Adverse reactions
Time frame: From enrollment to the end of follow-up at 11 months
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 28 Jan 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 1/2 study testing Semaglutide (1 Mg Dose) and Sitagliptin (DPP4 inhibitor) in people with Type 2 Diabetes, run by Second Affiliated Hospital of Guangzhou Medical University 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 3 inclusion and 4 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 28 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wangen Li, Dr (86-20-34152032, liwg660@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes remission rate (time frame: From enrollment to the end of follow-up at 11 months). 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 28 Jan 2026.