Type 2 Diabetes
Conditions
Brief summary
The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.
Interventions
HRS9531 injected subcutaneously once weekly.
Semaglutide injected subcutaneously once weekly.
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with type 2 diabetes ≥ 90 days； 2. Stable daily dose(s) for ≥3months prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors; 3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%; 4. Female patients of childbearing potential and male patients must agree to use highly effective contraception during the trial and for at least 2 months after the last dose of the investigational medicinal drug. Female patients of childbearing potential must test negative for pregnancy at Visit 1 and not be breastfeeding.
Exclusion criteria
1. Known or suspected allergy or intolerance to the investigational medicinal products or related products； 2. Acute complications of diabetes occurred during the previous 6 months； 3. Serious chronic complications of diabetes in the past； 4. Use other antidiabetic drugs for ≥3months prior to screening ; 5. Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying； or gastrointestinal surgery; 6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 3 months or 5 half-lives, whichever is longer, prior to screening; 7. Any conditions that the Investigator judges might not be suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0 to Week 36 | Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects with HbA1c≤6.5% | Week 0 to Week 36 | Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment. |
| Proportion of Subjects with HbA1c<7% | Week 0 to Week 36 | Proportion of subjects with HbA1c\<7% after 36 weeks of treatment. |
| Change in body weight | Week 0 to Week 36 | Change from baseline in body weight after 36 weeks of treatment. |
| 7-points SMPG profiles | Week 0 to Week 36 | Fluctuation of 7-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime. |
| Incidence and severity of adverse events | Week 0 to Week 52+4 weeks follow-up | Severity (mild, moderate and severe) is assessed by investigator. |
| Change in FPG (fasting plasma glucose) | Week 0 to Week 36 | Change from baseline in FPG after 36 weeks of treatment. |
Countries
China
Outcome results
None listed