Active — Not RecruitingPhase 3

A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise

China284 participantsStarted 2024-09-25

Plain-language summary

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with placebo in subjects with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Male or female, 18-75 age years, both inclusive;
✓. Type 2 diabetes mellitus diagnosed for at least 2 months before the screening visit;
✓. HbA1c 7.0-10.0% (both inclusive) at screening;
✓. Treated with diet and exercise, and without any antidiabetic drugs at least 8 weeks prior to screening.

Exclusion criteria

✕. Known or suspected allergy to the investigational drug or its components or excipients.
✕. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
✕. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
✕. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
✕. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

What they're measuring

Change from baseline in HbA1c at 32 weeks of treatment

Timeframe: at 32 weeks

Trial details

NCT IDNCT06672172

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-15

View on ClinicalTrials.gov More Type 2 Diabetes trials