Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus (TRED)

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Sitagliptin (DPP4 inhibitor); Drug: Semaglutide (1 Mg Dose)

Study type: Interventional

Funder types: Other

Identifiers

NCT07374328

TRED

Details and patient eligibility

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.).

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Semaglutide group: patients receive semaglutide treatment.

Experimental group

Description:

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.

Treatment:

Drug: Semaglutide (1 Mg Dose)

Oral medication group: patients receive triple hypoglycemic oral medications.

Active Comparator group

Description:

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).

Treatment:

Drug: Sitagliptin (DPP4 inhibitor)