A Study of CJC-1134-PC Injection in Antidiabetic Treatment-naive Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

NCT07058545 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2025-07-10

No results posted yet for this study

Summary

This study is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once Weekly in Antidiabetic Treatment-naive Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Conditions

  • Type 2 Diabetes Mellitus - Poor Control

Interventions

DRUG

CJC-1134-PC Injection

Double-blind Treatment Period: 0.2ml (2mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52)

DRUG

Placebo

Double-blind Treatment Period: 0.2ml (0mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52)

Sponsors & Collaborators

  • Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Linong Ji, Prof. · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2023-02-20
Completion
2023-02-20

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07058545 on ClinicalTrials.gov