NCT07374328 Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus
| NCT ID | NCT07374328 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 240 participants in total. It began in 2025-06-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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%. 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.).
Eligibility Criteria
Inclusion Criteria: * Patients with newly diagnosed type 2 diabetes. * Age between 18 and 65 years old. * HbA1c ≥ 9.0%. Exclusion Criteria: * Type 1 diabetes. * Elevated creatinine or urinary albumin/creatinine. * Combined with coronary heart disease, tumor or pregnancy. * Receiving glucocorticoids.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07374328 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07374328 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07374328 currently recruiting?
Yes, NCT07374328 is actively recruiting participants. Contact the research team at liwg660@126.com for enrollment information.
Where is the NCT07374328 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07374328 clinical trial?
NCT07374328 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 240 participants.
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