Janagliflozin Treat T2DM Monotherapy

Diabetes Type 2 Clinical Trial

Official title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled Study, to Evaluate the Efficacy and Safety of Janagliflozin (25 mg and 50 mg) as Monotherapy in Chinese Patients Diagnosed With T2DM

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

A multicentre, randomized, double-blind, parallel group, placebo-controlled study(24 weeks core period followed by 28 Weeks Extension period), to evaluate the efficacy and safety of Janagliflozin (25 mg and 50 mg) compared to placebo in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 390 patients with inadequate glycemic control with diet and exercise will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg once daily for 52 weeks, or 24 weeks of double-blind treatment with placebo followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg. During the treatment, if a patient's glycemic level remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally once daily. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

• NCT number: NCT03811548
• Study type: Interventional
• Source: Sihuan Pharmaceutical Holdings Group Ltd.
• Contact: Leili Gao, Doctor
• Phone: 00861088325578
• Email: plum_jj@sina.com
• Status: Recruiting
• Phase: Phase 3
• Start date: May 23, 2019
• Completion date: December 31, 2020