A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD

NCT06558708 | Recruiting Phase 2

• 1 other identifier: GZR101-T2D-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

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

  Week 0, week 16

Secondary Outcomes (4)

• Change in Fasting Plasma Glucose (FPG)

  Week 0, Week 16

• Change in 7-point SMPG profile

  Week 0, Week 16

• Incidence and Rate of Treatment-emergent AE/SAEs

  Week 0, Week 19

• Incidence and Rate of hypoglycemia Events

  Week 0, Week 19

Study Arms (2)

GZR101 Injection

EXPERIMENTAL

Participants will receive once daily GZR101 Injection with or without pre-dinner meal-time insulin, s.c, treat-to-target dose

Drug: GZR101 Injection

GZR33-70 Injection

EXPERIMENTAL

Participants will receive once daily GZR33-70 Injection with or without pre-dinner meal-time insulin, s.c., treat-to-target dose

Drug: GZR33 Injection; Drug: Insulin aspart

Interventions

GZR101 Injection DRUG

Once daily

GZR101 Injection

GZR33 Injection DRUG

Once daily

GZR33-70 Injection

Insulin aspart DRUG

Once daily

GZR33-70 Injection

Eligibility Criteria

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

You may qualify if:

• \. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
• At the age of 18-75 (inclusive) at the time of informed consent, male or female.
• Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
• Diagnosed with type 2 diabetes mellitus above or equal to 6 months.

You may not qualify if:

• Presence or history of malignant neoplasm prior to screening.
• Known or suspected hypersensitivity to investigational medical product(s) or related products.
• Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
• History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
• \. Participated in another interventional clinical study within 4 weeks prior to randomization.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Study Site 01

Tianjin, China

RECRUITING

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

• Clinical Transparency

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Central Study Contacts

Baozhuo Wang

CONTACT

01056456746; baozhuo.wang@ganlee.com

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: August 14, 2024
• First Posted: August 19, 2024
• Study Start: June 28, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)