A Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diab… (NCT06849843) | Clinical Trial Compass
CompletedPhase 2
A Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients.
China59 participantsStarted 2024-12-18
Plain-language summary
This is a study to evaluate the impact and efficacy of Efsubaglutide Alfa injection 3mg QoW on the treatment of type 2 diabetes patients with poor glycemic control after dietary and exercise intervention.
Primary objective:
To evaluate the effect and role of continuous treatment with 3mg of Efsubaglutide Alfa QoW and 1mg of Efsubaglutide Alfa QW for 12 weeks on HbA1c in T2DM patients with poor glycemic control after dietary and exercise intervention.
Secondary objectives:
1. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on glucose variability (change in time in range (TIR) relative to baseline) in T2DM patients with poor glycemic control after dietary and exercise intervention.
2. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on drug exposure (relative to 1mg QW) in T2DM patients with poor glycemic control after dietary and exercise intervention.
3. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on fasting plasma glucose (FPG) in T2DM patients with poor glycemic control after dietary and exercise intervention.
Who can participate
Age range18 Years – 75 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
✓. Male or female patients aged from 18 to 75;
✓. Type 2 diabetes diagonsed at least 8 weeks and has not received any glucose-lowering medication within 8 weeks prior to screening;
✓. During screening, HbA1c: 7.0% ≤ HbA1c ≤ 11.0%;
✓. Before randomization : 7.0% ≤ HbA1c ≤ 11.0%;
✓. During screening and before randomization: FPG\< 13.9 mmol/L
✓. 24 kg/m2 ≤ BMI ≤ 40 kg/m2;
✓. Without birth plan and voluntarily take effective contraceptive measures;
✓. Fully understood the study, voluntarily entered the study and signed the informed consent.
Exclusion criteria
✕. Diabetes other than Type 2;
✕. Any DPP-4 inhibitors and / or GLP-1 analogues were used within 3 months before screening;
. Continuous use of insulin for more than 14 days in the previous year;
✕. C-Peptide \<0.3 nmol/L;
✕. Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar non ketonic diabetic coma occurred within 6 months before screening;
✕. Unstable proliferative retinopathy or macular lesion, severe diabetic neuropathy, intermittent claudication or diabetic foot occurred within 6 months before screening;
✕. Severe hypoglycemia occurred within 6 months before screening
✕. Severe trauma infection or operation within one month before screening;