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SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin

NCT05801627 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2023-04-06

No results posted yet for this study

Summary

This is the phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in T2DM patients uncontrolled by metformin, 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 Metformin ≥1500mg

DRUG

Placebo

Placebo (2 tablet) and Metformin ≥1500mg

Sponsors & Collaborators

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaohui Guo, Ph.D · Peking University First Hospital

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
2020-05-06
Primary Completion
2022-05-24
Completion
2022-05-24

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 NCT05801627 on ClinicalTrials.gov