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 range18 Years – 70 Years
SexALL
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;
✓. 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);
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.
. 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;