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Clinical Trial NCT07487103 for Type 2 Diabetes is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Efficacy and Safety of QLG1090 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes Phase 3 478 Randomized Double-Blind Multi-Center

Not yet recruiting
Clinical Trial NCT07487103 is designed to study Treatment for Type 2 Diabetes. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 478 participants. Led by Qilu Pharmaceutical Co., Ltd., this study is expected to complete by 1 May 2027. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
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, double-blind, double-dummy, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.
Official Title

A Multicenter, Randomized, Double-blind, Double-dummy, 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

Conditions
Type 2 Diabetes
Other Study IDs
  • QLG1091-301
NCT ID Number
NCT07487103
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-23
Completion Date (Estimated)
2027-05
Enrollment (Estimated)
478
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalQLG1091
QLG1091
Oral administration once-daily.
Active ComparatorRybelsus
Rybelsus
Oral administration once-daily
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in HbA1c
Change from baseline in HbA1c was evaluated at Week 26
Week 26
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Female or male，age 18 to 75.
  2. Body mass index (BMI) ≥ 22 kg/m² and ≤ 35 kg/m² at screening.
  3. HbA1c of 7.0-10.5 %.
  4. Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening.
  5. 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.

  1. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
  2. History of pancreatitis (acute or chronic).
  3. 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).
  4. Subjects presently classified as being in New York Heart Association Class IV.
  5. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
  6. 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).
Qilu Pharmaceutical Co., Ltd. logoQilu Pharmaceutical Co., Ltd.
Study Central Contact
Contact: Fangyi Wang, Bachelor, +86-18266419923, [email protected]
No location data.