A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects With T2DM

• Status: Enrolling by invitation
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gan and Lee Pharmaceuticals, USA
• Treatments: Insulin; Insulin Aspart

Criteria

Inclusion Criteria:

• Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.

• BMI = 18.5-35 kg/m2 (inclusive) at screening.

• Diagnosed with type 2 diabetes mellitus for ≥ 6 months.

• 7.0% ≤ HbA1c ≤ 11.0% at screening.

Exclusion Criteria:

• Women in pregnancy or lactation.

• Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.

• Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.

• Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.

• Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.

• Known or suspected hypersensitivity to trial product(s).

• Participation in a clinical study of another study drug within 1 month prior to randomization.