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