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SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

NCT05782192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2023-03-23

No results posted yet for this study

Summary

This is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

SAL067

SAL067 6mg(2 tablet) and placebo 25mg (1 tablet)

DRUG

Alogliptin

Alogliptin 25mg(1 tablet) and placebo 6mg (2 tablet)

DRUG

Placebo

placebo 6mg (2 tablet) and placebo 25mg (1 tablet)

Sponsors & Collaborators

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Yan, Ph.D · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2022-03-25
Completion
2022-03-25

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05782192 on ClinicalTrials.gov