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

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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07374328
Acronym
TRED
Enrollment
240
Registered
2026-01-28
Start date
2025-06-01
Completion date
2026-08-31
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

triple regimen, diabetes, remission

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.).

Interventions

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 0.1g per day.

Sponsors

Second Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Diabetes remission rateFrom enrollment to the end of follow-up at 11 months

Secondary

MeasureTime frame
HbA1cFrom enrollment to the end of follow-up at 11 months
Hypoglycemia rateFrom enrollment to the end of follow-up at 11 months
Adverse reactionsFrom enrollment to the end of follow-up at 11 months

Countries

China

Contacts

CONTACTWangen Li, Dr
liwg660@126.com86-20-34152032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026