NCT07387003

Brief Summary

This study will be conducted to evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal Insulin.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for phase_2

Timeline
17mo left

Started Apr 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

January 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2027

Last Updated

April 15, 2026

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

January 28, 2026

Last Update Submit

April 10, 2026

Conditions

Type 2 Diabetes (T2DM)

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment.

    Baseline , 16 weeks

Secondary Outcomes (2)

  • Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment

    Baseline , 16 weeks

  • Safety Endpoints

    Baseline , 17 weeks

Study Arms (2)

GZR101-80

EXPERIMENTAL
Drug: GZR101-80

GZR33 or Insulin degludec/Insulin aspart or Insulin aspart 30 (NovoRapid®30)

ACTIVE COMPARATOR
Drug: GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)

Interventions

GZR101-80DRUG

Administered SC

GZR101-80
GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)DRUG

Administered SC

GZR33 or Insulin degludec/Insulin aspart or Insulin aspart 30 (NovoRapid®30)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and are able to follow the contraindications and restrictions specified in this protocol.
  • At the age of 18-75 (inclusive) at the time of informed consent, male or female.
  • Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.
  • According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.

You may not qualify if:

  • Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes, cystic fibrosis, pancreatitis, drug- or chemical-induced diabetes, etc.) prior to screening.
  • Grade 3 hypoglycemia within 3 months before screening.
  • Subjects who have any diseases that may affect HbA1c testing at screening, or subjects who have donated blood, lost more than 400 mL of blood, or received blood transfusion within 3 months prior to screening.
  • Diagnosis of active malignant tumor within 5 years prior to screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, in situ cancer of cervix, or prostate cancer in situ), or with a high suspicion of potential malignant tumor at screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gan & Lee Pharmaceuticals

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludecInsulin Aspart

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Wei Zhao

CONTACT

010-8059-5000wei.zhao@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

January 28, 2026

First Posted

February 4, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

February 11, 2027

Study Completion (Estimated)

September 23, 2027

Last Updated

April 15, 2026

Record last verified: 2025-09

Locations

CN(1)