NCT03811548

Janagliflozin Treat T2DM Monotherapy

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (estimated)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes Type 2

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-23
• Primary completion: 2020-06-24
• Completion: 2020-12-31
• First posted: 2019-01-22
• Last updated: 2020-07-16

Locations

1 site across 1 country: China