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Janagliflozin Treat T2DM Monotherapy

NCT03811548 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2020-07-16

No results posted yet for this study

Summary

The purpose of this study is to assess the effect of Janagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatment, overall safety and Population pharmacokinetics.

Conditions

  • Diabetes Type 2

Interventions

DRUG

Janagliflozin 25mg

Tablets, Oral, 25 mg, Tablets, Oral, 50 mg

DRUG

Janagliflozin 50mg

Tablets, Oral, 25 mg, Once daily, 52 weeks

DRUG

Placebo/Janagliflozin

Tablets, Oral, 25 mg, Once daily, 52 weeks

Sponsors & Collaborators

  • Sihuan Pharmaceutical Holdings Group Ltd.

    lead INDUSTRY

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
2019-05-23
Primary Completion
2020-06-24
Completion
2020-12-31

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 NCT03811548 on ClinicalTrials.gov