Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes
A Multicenter, Randomized, Open-label, Parallel-group, Active-controlled Clinical Trial to Evaluate Efficacy and Safety of QLG1091 Versus Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes
1 other identifier
interventional
478
0 countries
N/A
Brief Summary
This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started May 2026
Shorter than P25 for phase_3 type-2-diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2026
CompletedFirst Posted
Study publicly available on registry
March 23, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 28, 2026
March 1, 2026
7 months
March 17, 2026
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
Change from baseline in HbA1c was evaluated at Week 26
Week 26
Study Arms (2)
QLG1091
EXPERIMENTALRybelsus
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Female or male，age 18 to 75.
- Body mass index (BMI) ≥ 22 kg/m² and ≤ 35 kg/m² at screening.
- HbA1c of 7.0-10.5 %.
- Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening.
- Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose≥1000 mg/day) at least 90 days prior to the day of screening.
You may not qualify if:
- Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
- History of pancreatitis (acute or chronic).
- History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Subjects presently classified as being in New York Heart Association Class IV.
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2026
First Posted
March 23, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
April 28, 2026
Record last verified: 2026-03