A Study of CJC-1134-PC Injection in Patients With Type 2 Diabetes With Inadequately Controlled Blood Glucose Level After Metformin Monotherapy or Metformin in Combination With Insulin Secretagogues

NCT07057271 | Completed Phase 3

• 1 other identifier: CSCJC DM301
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Designed to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once A Week in Patients with Type 2 Diabetes with Inadequately Controlled Blood Glucose Level after Metformin Monotherapy or Metformin in Combination with Insulin Secretagogues.

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.
• Patients with type 2 diabetes diagnosed according to the World Health Organization (WHO) 1999 criteria and who have received metformin monotherapy or metformin in combination with insulin secretagogues at stable doses for at least 2 consecutive months at screening (a daily dose of NLT 1,500 mg or a maximum tolerated dose and NLT 1,000 mg/day for metformin, and a dose of NLT half of the maximum dose as recommended in local IFU or the maximum tolerated dose for insulin secretagogues).
• Patients with stable living habits 2 months prior to screening, e.g., stable dietary habits and physical activities;
• Patients with the fasting plasma glucose or fasting serum glucose at the clinical site and the fasting plasma glucose in the central laboratory of NMT 13.9 mmol/L (250 mg/dL) at screening period; with the fasting plasma glucose in the central laboratory of NMT 13.9 mmol/L (250 mg/dL) at V3;
• Patients with the HbA1c level of NLT 7.0% and NMT 11.0% at screening in local laboratory, and with the HbA1c level of NLT 7.0% and NMT 11.0% at screening and V3 in 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 the informed consent form.

You may not qualify if:

• Diagnosis of type 1 diabetes mellitus, or a specific type of diabetes mellitus caused by damage to the pancreas or other disease (such as acromegaly or Cushing syndrome);
• History of acute pancreatitis prior to screening or current history of acute or chronic pancreatitis.
• Active gallbladder or biliary tract disease within 1 year prior to screening (active refers to the presence of associated symptoms);
• Family or personal history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (family refers to first-degree relatives by blood);
• Individuals with a history of malignant tumors within the previous 5 years, except patients with cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
• Decompensated cardiac dysfunction (New York Heart Association cardiac class III or IV) within 6 months prior to screening or currently;
• Myocardial infarction, coronary artery bypass grafting, coronary stenting, hemorrhagic or ischemic stroke (except lacunar cerebral infarction), or hospitalization for unstable angina or transient ischemic attack within 6 months prior to screening;
• Uncontrolled and severe cardiac dysrhythmia \[e.g., second- or third-degree atrioventricular block, prolonged QT interval (QTc \>450 ms)\] 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;
• History of diabetic foot ulcer within 1 year prior to screening;
• Proliferative diabetic retinopathy within 6 months prior to screening or at the time of screening \[confirmed by fundus photography without mydriasis or by fundus examination with medicated mydriasis (unless mydriasis is contraindicated) by an eye health care provider, or a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to screening\];
• Diabetic ketoacidosis or hyperglycemic hyperosmolar state occurred within 6 months before screening to before randomization;
• History of 2 or more episodes of severe hypoglycemia within 6 months prior to screening or severe hypoglycemia between screening and pre-randomization (see Section 3.3.2.1 of version 1.2 of the protocol for definition of hypoglycemia);
• Previous (e.g., major or total gastrectomy, sleeve gastrectomy, gastric bypass) or current history of significant gastrointestinal disease (e.g., active ulcers, gastroparesis, pyloric obstruction, intestinal obstruction, inflammatory bowel disease, etc.) or chronic gastrastric-related surgery disease that requires long-term use of medications directly affecting gastrointestinal peristalsis and judged by the investigator to be unsuitable to participate in this trial;
• Severe trauma or moderate to major surgery within 1 month prior to screening and up to the time of randomization or the need for systemic use of anti-infective medications and, in the judgment of the investigator, the above conditions may affect glycemic control; Prohibited treatments 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 30, 2025
• First Posted: July 9, 2025
• Study Start: May 27, 2021
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)