A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes

ConditionT2DM
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Raynovent Biotech Co., Ltd

About this trial

The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have been diagnosed with type 2 diabetes mellitus (T2DM)

Have HbA1c between ≥7.0% and ≤11.5%

Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening

Be of stable weight (±5%) for at least 12 weeks before screening

Disqualifiers

Have type 1 diabetes mellitus

Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;

History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;

Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose <3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • RAY1225

    Drug

    Administered SC

  • Semaglutide

    Drug

    Administered SC

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: 6mg RAY1225Experimental treatment 1 intervention
Group B: 9mg RAY1225Experimental treatment 1 intervention
Group C: 1 mg SemaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg)

HbA1c is the glycosylated fraction of hemoglobin A.

Time frame
Baseline,36 Week

Secondary outcomes

1

Percentage of Participants Achieving an HbA1c Target Value of <7%

Time frame
Baseline,36 Week
2

Percentage of Participants With HbA1c Target Value of <6.5%

Time frame
Baseline,36 Week
3

Percentage of Participants With HbA1c Target Value of <5.7%

Time frame
Baseline,36 Week
4

Mean change in fasting serum glucose

Time frame
Baseline,36 Week

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: