At a glance
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Efficacy and Safety of Once-weekly Supaglutide Versus Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Supaglutide injection and placebo injection for Type2 Diabetes. Completed, enrolled 547 participants across 1 site.
Detailed Summary
This is a study to evaluate the efficacy and safety of Supaglutide injection in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention. This trial includes dosage determination (Phase IIb) and efficacy confirmation stage(Phase III). The primary outcome of the phase IIb period is to preliminarily evaluate the efficacy and safety of Supaglutide and to provide the recommended dosage for the Phase 3 period after 12-week treatment. The primary outcome of the Phase III period is to evaluate the efficacy and safety of Supaglutide after 24-week, double-blind treatment. The secondary outcome is to evaluate the efficacy and safety of Supaglutide after 24-week, double-blinded plus 28-week, open-label treatment period.
Study Details
Timeline
Interventions
Supaglutide 1mg/0.5ml , 2mg/0.5ml ,3mg /0.5ml
placebo injection 0.5ml