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NCT Number: NCT07374328

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

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.).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Second Affiliated Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location status: Recruiting

Location contact

Wangen Li, Dr

CONTACT

[email protected]

86-20-34152032

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sitagliptin (DPP4 inhibitor)

Drug

Sitagliptin 0.1g per day.

Primary outcomes

  1. Diabetes remission rate

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

Secondary outcomes

  1. HbA1c

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

  2. Hypoglycemia rate

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

  3. Adverse reactions

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

Study contacts

Contact information is provided by the study sponsor or research team.

Wangen Li, Dr

CONTACT

[email protected]

86-20-34152032

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study 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

Acronym: TRED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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