Comparing three-drug blood sugar regimens for adults newly diagnosed with type 2 diabetes
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
Run by Second Affiliated Hospital of Guangzhou Medical University · NCT07374328 · Data updated 2026-11-12
This test compares semaglutide versus sitagliptin, each given with metformin and empagliflozin, to see which better controls blood sugar and promotes remission in adults newly diagnosed with type 2 diabetes and HbA1c ≥ 9%.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07374328 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 years old with newly diagnosed type 2 diabetes and HbA1c ≥ 9.0% who do not have significant kidney disease, coronary heart disease, active cancer, pregnancy, or current glucocorticoid use.
✕Probably not a fit
People with type 1 diabetes, impaired renal function or albuminuria, existing coronary heart disease, active cancer, pregnancy, current steroid treatment, or those outside the specified age or HbA1c criteria are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, controlled Phase 1/2 study plans to enroll 240 adults aged 18–65 with newly diagnosed type 2 diabetes and HbA1c ≥ 9%. Participants are randomized to a semaglutide arm (0.25 mg weekly in month 1, 0.5 mg weekly in month 2, then 1.0 mg weekly months 3–8) or an oral arm with sitagliptin 0.1 g daily, and both arms also receive metformin 1.0 g daily and empagliflozin 10 mg daily. Key exclusions include type 1 diabetes, significant kidney disease or albuminuria, coronary heart disease, active malignancy, pregnancy, and current glucocorticoid use. The study will compare glycemic control and remission outcomes over the treatment period.
Why it matters
Potential benefit: If successful, the comparison could identify a regimen that achieves faster HbA1c reduction and higher rates of diabetes remission, potentially lowering long-term complication risk.
How similar studies have gone: Prior studies show GLP-1 receptor agonists like semaglutide produce larger HbA1c and weight reductions and can lead to remission in some newly diagnosed patients, while DPP-4 inhibitors such as sitagliptin are generally less potent, so this approach builds on existing evidence.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
The Second Affiliated Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Wangen Li, Dr
- Email: liwg660@126.com
- Phone: 86-20-34152032
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.