A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 1\. 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.

• 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.

• 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.

• 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.

Locations
Other Locations
China
Study Site 01
RECRUITING
Tianjin
Contact Information
Primary
Baozhuo Wang
baozhuo.wang@ganlee.com
01056456746
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2024-12
Participants
Target number of participants: 60
Treatments
Experimental: GZR101 Injection
Participants will receive once daily GZR101 Injection with or without pre-dinner meal-time insulin, s.c, treat-to-target dose
Experimental: GZR33-70 Injection
Participants will receive once daily GZR33-70 Injection with or without pre-dinner meal-time insulin, s.c., treat-to-target dose
Related Therapeutic Areas
Sponsors
Leads: Gan and Lee Pharmaceuticals, USA

This content was sourced from clinicaltrials.gov