Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • QLG1091
  • Rybelsus

Treatment groups

478 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators