A Study of CJC-1134-PC Injection in Patients With Type 2 Diabetes With Inadequately Controlled Bl… (NCT07057271) | Clinical Trial Compass
CompletedPhase 3
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
China464 participantsStarted 2021-05-27
Plain-language 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.
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.
. 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;
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 IDNCT07057271
SponsorChangshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.
. 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.
Exclusion criteria
. 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;