RecruitingPhase 3NCT06589765

A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin

A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)


Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

800 participants

Start Date

Sep 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new investigational diabetes drug called HRS-7535 against an existing medication (dapagliflozin) for people with Type 2 diabetes whose blood sugar is not well controlled on metformin alone. The goal is to see if the new drug controls blood sugar as well or better. **You may be eligible if...** - You are between 18 and 75 years old - You have had Type 2 diabetes for at least 3 months - Your HbA1c (a measure of blood sugar control over 3 months) is between 7.5% and 11% - You have been on a stable dose of metformin (at least 1,500 mg/day) for at least 8 weeks **You may NOT be eligible if...** - You have Type 1 diabetes or another form of diabetes - You have had a serious diabetes emergency (e.g., ketoacidosis) in the past 6 months - You have active eye complications, painful nerve damage, a diabetic foot ulcer, or severe circulation problems requiring treatment - You are pregnant, breastfeeding, or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-7535 tablet

HRS-7535 tablet

DRUGdapagliflozin tablet

dapagliflozin tablet


Locations(1)

Beijing Hospital

Beijing, Beijing Municipality, China

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NCT06589765


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