Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus
Recruiting · NCT07374328 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.).
Who can take part
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 is running
1 location listed.
- The Second Affiliated Hospital, Guangzhou Medical University - Guangzhou, Guangdong, China