T2DM, Type 2 Diabetes Mellitus
Conditions
Keywords
T2DM, Glucagon-like peptide-1, Ecnoglutide, XW003, GLP-1
Brief summary
The main purpose of this study is to investigate the efficacy and safety of XW003 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone
Detailed description
In this Phase 3 study, eligible participants will be randomized in a 2:2:1:1 ratio to receive once-weekly subcutaneous XW003 (high or low dose) or volume matching placebo as an adjunct to lifestyle intervention for 24 weeks. The core treatment phase will be followed by a 28-week open-label period where all participants receive XW003.
Interventions
DRUGEcnoglutide
Subcutaneous Injection
DRUGPlacebo
Subcutaneous Injection with matched volume
Sponsors
Hangzhou Sciwind Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures. 2. Sex: male or female; Age: 18 to 75 years, inclusive 3. BMI: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive 4. Have been diagnosed with T2DMthat is inadequately controlled with at least 3 months of diet and exercise prior to screening. 5. HbA1c ranging from 7.5% to 11.0% at screening, inclusive 6. FPG ≤13.9 mmol/L at screening.
Exclusion criteria
1. History of type 1 or other types of diabetes mellitus. 2. Use of any GLP-1 analogue during the 3 months preceding to screening. 3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening. 4. History of acute or chronic pancreatitis or high risk factors for pancreatitis. 5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. 6. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months. 7. History of heart attack, stroke, or congestive heart failure of Grade 3 or 4 in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | Baseline, Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in lipid panel | Baseline, Week 24 and Week 52 |
| Change from baseline in body weight | Baseline, Week 24 and Week 52 |
| Change from baseline in waist circumference | Baseline, Week 24 and Week 52 |
| Change from baseline in hip circumference | Baseline, Week 24 and Week 52 |
| Change from baseline in HbA1c | Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52 |
| Proportion of subjects with HbA1c < 7% and HbA1c ≤6.5% after treatment | week 24, week 52 |
| Proportion of subjects with HbA1c < 7%, with no severe hypoglycemia or no weight gain | week 24 |
| Change from baseline in fasting plasma glucose (FPG) | Baseline, Week 24 and Week 52 |
| Change from baseline in fasting insulin | Baseline, Week 24 and Week 52 |
| Change from baseline in 2-hour postprandial blood glucose | Baseline, Week 24 and Week 52 |
| Change from baseline in 7-point self-monitored blood glucose | Baseline, Week 24 and Week 52 |
| Change from baseline in HOMA-IR | Baseline, Week 24 and Week 52 |
| Change from baseline in HOMA-β | Baseline, Week 24 and Week 52 |
Other
| Measure | Time frame |
|---|---|
| Immunogenecity of XW003 | Baseline, D85, D168, D253, D399 |
| Pharmacokinetics: plasma trough level of XW003 | Baseline, D29, D57, D85, D168, D197, D225, D253, D364, D399 |
| Incidence of adverse events | from baseline to EOS |
Countries
China
Outcome results
None listed