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

NCT07058545 | Completed Phase 3

• 1 other identifier: CSCJC DM302
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c at the end of double-blind treatment period.

  The double-blind treatment period ended at the 25-week visit.

  Week 25 visit

Secondary Outcomes (19)

• Proportion of subjects with HbA1c <7.0% at the end of the double-blind/open-label treatment period.

  Week 25 visit, and week 53 visit.

• Proportion of subjects with HbA1c <6.5% at the end of the double-blind/open-label treatment period.

  Week 25 visit, and week 53 visit.

• Changes from baseline in fasting weight at the end of double-blind/open-label treatment period.

  Week 25 visit, and week 53 visit.

• Changes from baseline in fasting waist circumference at the end of double-blind /open-label treatment period.

  Week 25 visit, and week 53 visit.

• Changes from baseline in fasting plasma glucose at the end of double-blind/open-label treatment period.

  Week 25 visit, and week 53 visit.

Study Arms (2)

CJC-1134-PC

EXPERIMENTAL

Injection, 0.2ml/2mg (prefilled pen)

Drug: CJC-1134-PC Injection

Placebo

PLACEBO COMPARATOR

Injection, 0.2ml/0mg (prefilled pen)

Drug: Placebo

Interventions

CJC-1134-PC Injection DRUG

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)

CJC-1134-PC

Placebo DRUG

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)

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18 - 70 years (inclusive) at screening;
• Subjects with body mass index (BMI) ≥ 20 kg/ m2 and ≤ 40 kg/ m2.
• Subjects diagnosed with type 2 diabetes mellitus according to 1999 World Health Organization (WHO) criteria;
• Subjects who had not received anti-diabetic therapy (including oral and injectable drugs, Chinese herbs for hypoglycemic purposes, and investigational anti-diabetic products, etc.) within 3 months prior to screening and had used anti-diabetic drugs for no more than 2 weeks since diagnosis;
• Subjects with a stable lifestyle prior to screening, e.g. no significant changes in diets and physical exercise;
• Subjects with fasting plasma glucose (FPG) or fasting serum glucose ≤13.9 mmol/L (250 mg/dL) at screening as determined by the local laboratory (study center) and FPG≤13.9 mmol/L (250 mg/dL) as determined by the central laboratory;
• Subjects with HbA1c levels ≥ 7.0% and ≤ 11.0% at screening as determined by the local laboratory (study center), and HbA1C ≥ 7.0% and ≤ 11.0% as determined by the central laboratory;
• Patients who were able to understand the procedures and methods of the study, willing to strictly comply with the clinical trial protocol, and voluntarily signed an informed consent form (ICF).

You may not qualify if:

• Subjects were not eligible for the study if they met any of the following criteria:
• Prior and concomitant diseases
• Diagnosed as type 1 diabetes mellitus, diabetes mellitus due to pancreatic injury, or secondary diabetes mellitus caused by other diseases (e.g., acromegaly or Cushing syndrome);
• History of acute and chronic pancreatitis prior to screening or current history of acute and chronic pancreatitis;
• Presence of active gallbladder or biliary tract disease within 1 year prior to screening (active means presence of relevant symptoms);
• Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (family refers to first-degree blood relatives);
• Presence of malignant tumors in the past 5 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix).
• Decompensated cardiac insufficiency (New York Heart Association class III or IV) either within the 6 months prior to screening or currently;
• History of myocardial infarction, coronary artery bypass grafting, coronary stenting, haemorrhagic or ischaemic stroke (except lacunar cerebral infarction), or hospitalisation for unstable angina pectoris or transient ischaemic attack within 6 months prior to screening;
• Uncontrolled and severe arrhythmia \[e.g., degree II or III AV block, prolonged QT interval (QTc \> 450 ms)\] within 6 months prior to screening and judged by the investigator to be unsuitable for participation in this trial;
• Severe diabetic neuropathy within 6 months prior to screening;
• Proliferative diabetic retinopathy diagnosed within 6 months before or at the time of screening, either confirmed by non-mydriatic fundus photography or by pharmacologically dilated fundus examination performed by an ophthalmic healthcare provider (unless contraindicated), or with a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to screening;
• Diabetic ketoacidosis or hyperglycemic hyperosmolar state occurring within 6 months prior to screening and up to randomization;
• Previous major gastric-related surgery (e.g., major or total gastrectomy, sleeve gastrectomy, gastric bypass), current history of significant gastrointestinal conditions (such as active ulcers, gastroparesis, pyloric obstruction, intestinal obstruction, inflammatory bowel disease, etc.), or chronic gastrointestinal diseases requiring prolonged use of medications that directly affect gastrointestinal motility and are deemed unsuitable for participation in this trial by the investigator;
• Severe trauma or major surgery occurring within 1 month prior to screening up to randomization, or the systemic use of antimicrobial agents, as determined by the investigator, which may potentially impact blood glucose control; Prohibited therapies and/or drugs

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Study Officials

• Linong Ji, Prof.

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 10, 2025
• Study Start: April 16, 2021
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)