Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide (1 Mg Dose), Sitagliptin (DPP4 inhibitor).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Drug Semaglutide (1 Mg Dose)
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 Sitagliptin (DPP4 inhibitor)
Sitagliptin 0.1g per day.
Primary outcome measures
- Diabetes remission rate [Time frame: From enrollment to the end of follow-up at 11 months]
Secondary outcome measures (3)
- HbA1c [Time frame: From enrollment to the end of follow-up at 11 months]
- Hypoglycemia rate [Time frame: From enrollment to the end of follow-up at 11 months]
- Adverse reactions [Time frame: From enrollment to the end of follow-up at 11 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital, Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT07374328 · TRED