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

Gan and Lee Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: insulin degledec/insulin aspart

Drug: GZR101

Study type

Interventional

Funder types

Industry

Identifiers

NCT06199505

GL-GZR-CH2006

Details and patient eligibility

About

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.

Enrollment

153 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.