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Janagliflozin Treat Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Metformin

NCT03851432 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2020-07-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Janagliflozin compared to placebo, both in combination with Metformin, in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with Metformin alone.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Janagliflozin plus metformin

Janagliflozin: Tablets, Oral, 25 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.

DRUG

Janagliflozin plus metformin

Janagliflozin: Tablets, Oral, 50 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.

DEVICE

Placebo plus metformin

Placebo: Tablets, Oral, 25/50 mg, Once daily, 24 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.

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
2019-06-30
Primary Completion
2020-04-30
Completion
2021-12-31

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 NCT03851432 on ClinicalTrials.gov