Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Beinaglutide
DrugBeinaglutide (continuous subcutaneous infusion)
Insulin aspart
DrugInsulin aspart (CSII)
Treatment groups
115 Participants
are divided into 2 treatment groupsGroup A: Continuous Beinaglutide infusionExperimental treatment 1 intervention
Group B: Continuouns Insulin aspart infusionActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
The primary endpoint of the trial is a composite endpoint of 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..
Time frame
From baseline to the end of treatment at 8 weekSecondary outcomes
1
Proportion of subjects achieving HbA1c reduction <7% after 8 weeks of treatment.
Proportion of participants achieving a reduction in HbA1c levels to below 7% after 8 weeks of treatment.
Time frame
From baseline to the end of treatment at 8 week2
Changes in fasting blood glucose from baseline after 8 weeks of treatment.
Changes in fasting blood glucose from baseline after 8 weeks of treatment.
Time frame
From baseline to the end of treatment at 8 week3
Changes in postprandial blood glucose from baseline after 8 weeks of treatment.
Changes in postprandial blood glucose from baseline after 8 weeks of treatment.
Time frame
From baseline to the end of treatment at 8 week4
Changes in HbA1C from baseline after 8 weeks of treatment.
Changes in HbA1C from baseline after 8 weeks of treatment.
Time frame
From baseline to the end of treatment at 8 weekSponsors and contacts
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Source ClinicalTrials.gov