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

NCT04994288 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 547

Last updated 2024-08-07

No results posted yet for this study

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.

Conditions

  • Type2 Diabetes

Interventions

BIOLOGICAL

Supaglutide injection

Supaglutide 1mg/0.5ml , 2mg/0.5ml ,3mg /0.5ml

OTHER

placebo injection

placebo injection 0.5ml

Sponsors & Collaborators

  • Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

    lead OTHER

Principal Investigators

  • Dalong Zhu, M.D,Ph.D · Nanjing trum tower hospital affiliated to Nanjing university school of medizine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2023-06-20
Completion
2023-08-16

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04994288 on ClinicalTrials.gov