Health TrialsbyHealthPanel

Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, able and willing to provide a written informed consent

Diagnosed with type 2 diabetes ≥ 90 days；

On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;

HbA1c was 7.5%~11.0% (both inclusive);

Disqualifiers

A history of type 1 diabetes, specific diabetes, or secondary diabetes;

Have a history of severe hypoglycemia within t180 days prior to screening;

History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；

Have a history of malignancy within 5 years;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS9531

    Drug

    HRS9531-low dose

  • HRS9531

    Drug

    HRS9531-high dose

  • Placebo

    Drug

    Placebo

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Treatment group A: HRS9531-low doseExperimental treatment 1 intervention
Group B: Treatment group B: HRS9531-high doseExperimental treatment 1 intervention
Group C: Treatment group CPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1c

Change in HbA1c after 40 weeks of treatment.

Time frame
from baseline to Week 40

Secondary outcomes

1

Proportion of subjects reaching HbA1<7.0%

Proportion of subjects reaching HbA1\<7.0% after 40 weeks of treatment.

Time frame
from baseline to Week 40
2

Proportion of subjects reaching HbA1≤6.5%

Proportion of subjects reaching HbA1≤6.5% after 40 weeks of treatment.

Time frame
from baseline to Week 40
3

Change in FPG

Change in FPG after 40 weeks of treatment.

Time frame
from baseline to Week 40
4

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score

Change from baseline in DTSQs after 40 weeks of treatment.

Time frame
From baseline to Week 40

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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