A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: B1: XW003+MET High dosage of XW003 once weekly |
Drug: Ecnoglutide high dosage
Administered subcutaneously
Other Names:
Drug: Metformin
Administered orally
|
| Experimental: B2: XW003+MET Low dosage of XW003 once weekly |
Drug: Ecnoglutide low dosage
Administered subcutaneously
Other Names:
Drug: Metformin
Administered orally
|
| Active Comparator: B3: Dulaglutide+MET 1.5mg Dulaglutide once weekly |
Drug: Dulaglutide
Administered subcutaneously
Drug: Metformin
Administered orally
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in HbA1c [Baseline, week 32]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures
-
Sex: male or female; Age: 18 to 75 years, inclusive
-
BMI: 20.0 kg/m2 to 35.0 kg/m2, inclusive
-
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.
-
HbA1c ranging from 7.5% to 11.0% at screening, inclusive
-
FPG ≤13.9 mmol/L at screening
Exclusion Criteria:
-
History of type 1 or other types of diabetes mellitus
-
Use of insulin during the 6 months preceding screening
-
History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening.
-
History of acute or chronic pancreatitis or high-risk factors for pancreatitis
-
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
-
History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
-
History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ZHONGSHAN Hospital | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Hangzhou Sciwind Biosciences Co., Ltd.
Investigators
- Principal Investigator: Xiaoying Li, Dr, Shanghai Zhongshan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCW0502-1032