Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Newly Diagnosed Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The efficacy, safety and post-treatment disease control will be compared between treatments consisting of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Hospital
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Patients aged 18 to 70 years (including 18- and 70-year-olds) at the time of enrollment regardless of gender;

• Patients who are willing to sign the informed consent form voluntarily;

• Patients diagnosed with type 2 diabetes based on the WHO 1999 diagnostic criteria with a disease duration of < 1 year;

• Patients with HbA1c levels between 9% and 12.0% or fasting blood glucose levels greater than 11.1 mmol / L;

• Patients with BMIs between 24 and 45 kg / m2;

• Patients who have not taken or have taken hypoglycemic agents for less than a month or patients who are not receiving any ongoing systematic treatment with oral hypoglycemic drugs (have taken hypoglycemic drugs for less than three months in the past but have stopped taking drugs more than three months earlier);

• Fertile female patients (or male subjects with fertile female partners) who agree to use effective contraceptives throughout the course of the study until one full month after the last treatment dosage.

Exclusion Criteria:

• Patients with type 1 or other types of diabetes;

• Patients with a history of obstructive bowel disease or such possible complications; patients with intestinal adhesions or obstructions caused by abdominal surgery or peritoneal infection; patients with reduced intestinal motilities or habitual constipation or patients with histories of immunologically based inflammatory bowel disease (IBD), Crohn's disease (CD) or ulcerative colitis (UC);

• Past diagnosis of pancreatitis;

• Family history of medullary thyroid carcinoma;

• Patients with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels that are greater than 3 times the normal upper limit and/or bilirubin levels greater than 2 times the normal upper limit;

• Patients with an above-moderate degree of renal insufficiency (eGFR < 60 ml / min / 1.73 m2);

• Triglyceride levels ≥ 5.0 mmol / L;

• Multiple endocrine neoplasia 2 (MEN 2);

• Patients who have participated in a pre-market trial drug within the last three months;

• Patients receiving treatments with systemic hormones (including glucocorticoids), immunosuppressants or cytotoxic drugs or who are anticipating such treatments during the course of the study;

• Patients with severe ketosis or ketoacidosis less than one month prior to screening;

• Patients with blood pressure above the following values (untreated or after treatments): systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;

• Within three months before the screening visit, patients have suffered one of following cardiovascular illnesses: acute myocardial infarction or congestive heart failure (cardiac functional capacity III/IV based on the New York Heart Association criteria or left ventricular ejection fraction ≤ 40%) or patients who have experienced cerebrovascular incidents (stroke);

• Patients with inflammatory bowel disease;

• Patients who are allergic to the test drug (Beinaglutide) or any of its other components and those who are allergic to the insulin reagent used in the study or any of its ingredients;

• Patients who have certain serious diseases that may interfere with the study and are not suitable to participate, as determined by the investigators;

• Pregnant women or women who are breastfeeding;

• Patients whose compliance is considered poor by the investigators, such that the study cannot be completed as required;

• Patients who are not suitable candidates to receive continuous pumping, such as those who are allergic to subcutaneous infusion tubes or tapes; those who are not willing to allow subcutaneous embedment of infusion tubes or to wear pumps for a long period of time; those who do not wish to receive medication via a pump; those who fail to master correct use after training sessions due to a lack of appropriate knowledge of the patients themselves or their family members; those with severe psychological or mental disorders or those who, without any guardians, are not capable of taking care of themselves;

• Patients who are not eligible to participate in this study due to factors identified by the investigators.