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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital of Guangzhou Medical University

About this trial

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.).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with newly diagnosed type 2 diabetes.

Age between 18 and 65 years old.

HbA1c ≥ 9.0%.

Disqualifiers

Type 1 diabetes.

Elevated creatinine or urinary albumin/creatinine.

Combined with coronary heart disease, tumor or pregnancy.

Receiving glucocorticoids.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Semaglutide group: patients receive semaglutide treatment.Experimental treatment 1 intervention
Group B: Oral medication group: patients receive triple hypoglycemic oral medications.Active comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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