Type 2 Diabetes
Conditions
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.
Interventions
HS-20094 injected subcutaneously once weekly
DRUGHS-20094 Placebo Injection
HS-20094 Placebo injected subcutaneously once weekly
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females, Age ≥18 years at the time of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening. 3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening. 4. 7.5% ≤ HbA1c ≤10.5% at screening.
Exclusion criteria
1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening. 2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.). 4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ； 5. Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening. 6. Participated in clinical trials of any drug or medical device within 12 weeks prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0 to Week 44 | Change from baseline in HbA1c after 44 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FPG | Week 0 to Week 44 | Change from baseline in FPG after 44 weeks of treatment |
| Change in body weight | Week 0 to Week 44 | Change from baseline in Change in body weight after 44 weeks of treatment |
| Proportion of subjects with HbA1c<7.0% and ≤6.5% | Week 0 to Week 44 | Proportion of subjects with HbA1c\<7.0% and ≤6.5% after 44 weeks of treatment |
| Change in HbA1c | Week 0 to Week 52 | Change from baseline in HbA1c after 52 weeks of treatment |
| Incidence and severity of adverse events | Week 0 to Week 52+4 weeks follow-up | Severity (mild, moderate and severe) is assessed by investigator |
| Proportion of subjects with weight loss ≥5% and ≥10% | Week 0 to Week 44 | Proportion of subjects with weight loss ≥5% and ≥10% after 44 weeks of treatment |
Countries
China
Outcome results
None listed