A Study of CJC-1134-PC Injection in Antidiabetic Treatment-naive Patients With Type 2 Diabetes Me… (NCT07058545) | Clinical Trial Compass
CompletedPhase 3
A Study of CJC-1134-PC Injection in Antidiabetic Treatment-naive Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
China474 participantsStarted 2021-04-16
Plain-language 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
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in HbA1c at the end of double-blind treatment period.
Timeframe: Week 25 visit
Trial details
NCT IDNCT07058545
SponsorChangshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.
. 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).
Exclusion criteria
. 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;