NCT04994288

A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients(SUPER-1)

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial includes a 2-week screening period, a 4-week induction period, a 24-week double-blind treatment period and a 28-week open-label treatment period, followed by a 4-week follow-up period and a follow-up visit. sample size was calculated to be 552, including 140 subjects in the period of Phase IIb and 412 subjects in the period of Phase III. Subjects were randomly assigned to once-weekly subcutaneously injected Supaglutide 1mg, 2mg, 3mg and placebo according to a 2:2:2:1 ratio. During the IIb period, after Interim analysis and IDMC(Independent Data Monitoring Committee) confirmed the RP3D ( Recommended phase 3 dosage ) high and low doses, subjects were randomly assigned to Supaglutide RP3D high dose, RP3D low dose and placebo group according to a 2:2:1 ratio.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Supaglutide injection	Supaglutide 1mg/0.5ml , 2mg/0.5ml ,3mg /0.5ml
OTHER	placebo injection	placebo injection 0.5ml

Timeline

• Start date: 2021-08-03
• Primary completion: 2023-06-20
• Completion: 2023-08-16
• First posted: 2021-08-06
• Last updated: 2024-08-07

Locations

1 site across 1 country: China