Comparing three-drug blood sugar regimens for adults newly diagnosed with type 2 diabetes
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 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 |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07374328 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.