Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly… (NCT03987308) | Clinical Trial Compass
RecruitingNot Applicable
Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
China115 participantsStarted 2019-07-02
Plain-language summary
The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.
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
✓. Age 18 to 70 years (inclusive) at enrollment, regardless of gender.
✓. Voluntary signing of the informed consent form.
✓. Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year.
✓. HbA1c between 7.5% and 10.0%.
✓. BMI between 24 kg/m² and 42 kg/m².
✓. Subjects who have not taken antidiabetic medications or have used oral antidiabetic medications for less than 3 months and have discontinued for more than 1 month (calculated from the date of signing the informed consent form).
✓. Subjects with reproductive potential (including male subjects whose partners have reproductive potential) agree to use effective contraception during the study and for 1 month after study completion.
Exclusion criteria
✕. Patients with type 1 diabetes or other types of diabetes.
✕. History of obstructive intestinal diseases or potential complications: subjects with post-abdominal surgery or peritoneal infection-related intestinal adhesions, intestinal obstruction sequelae; subjects with intestinal motility disorders, chronic constipation; subjects with a history of Crohn's disease or ulcerative colitis.
✕. History of pancreatitis.
✕. Family history of medullary thyroid carcinoma.
What they're measuring
1
The proportion of subjects achieving HbA1c <7.0%, no weight increase (≤0 kg), and no hypoglycemia (blood glucose ≤3.9 mmol/L or severe hypoglycemia) after 8 weeks of treatment.
Timeframe: From baseline to the end of treatment at 8 week