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

NCT07374328 | Recruiting Phase 1

• 1 other identifier: TRED
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.).

Conditions

Type 2 Diabetes

Keywords

triple regimen; diabetes; remission

Outcome Measures

Primary Outcomes (1)

• Diabetes remission rate

  From enrollment to the end of follow-up at 11 months

Secondary Outcomes (3)

• HbA1c

  From enrollment to the end of follow-up at 11 months

• Hypoglycemia rate

  From enrollment to the end of follow-up at 11 months

• Adverse reactions

  From enrollment to the end of follow-up at 11 months

Study Arms (2)

Semaglutide group: patients receive semaglutide treatment.

EXPERIMENTAL

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.

Drug: Semaglutide (1 Mg Dose)

Oral medication group: patients receive triple hypoglycemic oral medications.

ACTIVE COMPARATOR

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).

Drug: Sitagliptin (DPP4 inhibitor)

Interventions

Semaglutide (1 Mg Dose) DRUG

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.

Semaglutide group: patients receive semaglutide treatment.

Sitagliptin (DPP4 inhibitor) DRUG

Sitagliptin 0.1g per day.

Oral medication group: patients receive triple hypoglycemic oral medications.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed type 2 diabetes.
• Age between 18 and 65 years old.
• HbA1c ≥ 9.0%.

You may not qualify if:

• Type 1 diabetes.
• Elevated creatinine or urinary albumin/creatinine.
• Combined with coronary heart disease, tumor or pregnancy.
• Receiving glucocorticoids.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

semaglutide; Sitagliptin Phosphate; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

Wangen Li, Dr

CONTACT

86-20-34152032; liwg660@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 28, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)