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Safety and Efficacy of THR-1442 Compared to Dapagliflozin as Add-on Therapy to Metformin in T2DM

NCT05159882 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2021-12-16

No results posted yet for this study

Summary

The purpose of this study is to investigate the effect of THR-1442 compared to Dapagliflozin as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

Conditions

  • T2DM

Interventions

DRUG

THR-1442 and Dapagliflozin placebo

THR-1442 tablets 20mg and Dapagliflozin tablets placebo

DRUG

Dapagliflozin 10mg and THR1442 placebo

Dapagliflozin tablets 10mg and THR-1442 tablets placebo

Sponsors & Collaborators

  • Newsoara Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-09-30
Completion
2022-09-30

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 NCT05159882 on ClinicalTrials.gov