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

NCT06199505 | Completed Phase 2

• 1 other identifier: GL-GZR-CH2006
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment

  Baseline to week 16

Secondary Outcomes (5)

• Change in Fasting Plasma Glucose (FPG)

  Baseline to Week 16

• The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16

  Week 16

• Incidence and Rate of hypoglycemia Events

  Baseline to Week 16

• Incidence and Rate of Treatment-emergent AE/SAEs

  Baseline to Week 16

• Change from baseline in ADA and Nab

  Baseline to Week 16

Other Outcomes (1)

• Change from Baseline in Body Weight

  Baseline to Week 16

Study Arms (2)

GZR101

EXPERIMENTAL

GZR101 injection s.c., once daily, treat-to-target dose

Drug: GZR101

insulin degludec/insulin aspart,

ACTIVE COMPARATOR

insulin degludec/insulin aspart injection s.c., once or twice daily, treat-to-target dose

Drug: insulin degledec/insulin aspart

Interventions

GZR101 DRUG

Once daily

GZR101

insulin degledec/insulin aspart DRUG

Once daily or twice daily

insulin degludec/insulin aspart,

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• % ≤ HbA1c ≤ 11.0% at screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Chunyue Hao, PhD

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: November 21, 2023
• Primary Completion: June 28, 2024
• Study Completion: July 12, 2024
• Last Updated: January 17, 2025

Record last verified: 2023-12

Locations

CN (1)