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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
442
Tablets, Oral, 25 mg, Tablets, Oral, 50 mg
Tablets, Oral, 25 mg, Once daily, 52 weeks
Tablets, Oral, 25 mg, Once daily, 52 weeks
Linong Ji
Beijing, Beijing Municipality, China
RECRUITINGChange in HbA1c From Baseline to Week 24
To examine whether the mean change in HbA1c from baseline to week 24 with Janagliflozin is superiority (superiority margin of 0.5%) to placebo
Time frame: Baseline and Week 24
Change in HbA1c From Baseline to Week 52
To compare the mean change in HbA1c from baseline to week 52 between groups
Time frame: Baseline and Week 52
Percentage of Patients With HbA1c <7% at Week 24 (Core period) and week 52
To compare the percentage of patients with HbA1c \<7% at week 24 (core period) and week 52 (extension period) between groups
Time frame: Baseline, Week 24 and week 52
Percentage of Patients With HbA1c <6.5% at Week 24 (Core period) and Week 52 (Extension period)
To compare the percentage of patients with HbA1c \<6.5% at week 24 (core period) and Week 52 (extension period) between groups
Time frame: Baseline, Week 24 and Week 52
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in fasting plasma glucose (FPG) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Time frame: Baseline, Week 24 and Week 52
Change in 2-hour Post-prandial Glucose From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in 2-hour post-prandial glucose from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Time frame: Baseline, Week 24 and Week 52
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Change in Blood Lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in blood lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Time frame: Baseline, Week 24 and Week 52
Change in Blood Pressure (systolic blood pressure and diastolic blood pressure) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in blood pressure (systolic blood pressure and diastolic blood pressure) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Time frame: Baseline, Week 24 and Week 52
Change in Body Weight From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in body weight from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Time frame: Baseline, Week 24 and Week 52
Change in Fasting C-peptide From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in fasting C-peptide from Baseline to Week 24 (core period) and Week 52 (extension period) between groups.
Time frame: Baseline, Week 24 and Week 52
Change in Insulin Sensitivity From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in insulin sensitivity from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Time frame: Baseline, Week 24 and Week 52
Change in β-cell Function From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in β-cell function from Baseline to Week 24 (core period) and Week 52 (extension period) between groups.
Time frame: Baseline, Week 24 and Week 52
Percentage of Patients Who Have Received Rescue Therapy at Week 24 (Core period) and Week 52 (Extension period)
To compare the percentage of patients who have received rescue therapy by Week 24 (core period) and Week 52 (extension period) between groups
Time frame: Week 24 and Week 52