T2DM, Type 2 Diabetes Mellitus
Conditions
Keywords
T2DM, Glucagon-like peptide-1, GLP-1, Ecnoglutide, XW003
Brief summary
The aim of the study is to compare the efficacy and safety of two XW003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)
Detailed description
In this Phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous XW003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.
Interventions
Administered subcutaneously
Administered subcutaneously
DRUGDulaglutide
Administered subcutaneously
DRUGMetformin
Administered orally
Sponsors
Hangzhou Sciwind Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks 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 insulin during the 6 months preceding screening 3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to 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 32 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52 |
| Change from baseline in fasting plasma glucose (FPG) | Baseline, Week 32 and Week 52 |
| Change from baseline in lipid panel | Baseline, Week 32 and Week 52 |
| Change from baseline in body weight | Baseline, Week 32 and Week 52 |
| Pharmacokinetics: plasma trough level of XW003 | Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399 |
Countries
China
Outcome results
None listed