A Phase 3 interventional study of Janagliflozin 25mg and Janagliflozin 50mg in Diabetes Type 2, sponsored by Sihuan Pharmaceutical Holdings Group Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-07-16.
Sponsored by Sihuan Pharmaceutical Holdings Group Ltd. · Phase 3, Interventional, and Treatment
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.
9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.
This study's planned enrollment of 442 is above the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Sihuan Pharmaceutical Holdings Group Ltd. is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any laboratory test indicators meet the following standards:
Each patient will receive 25 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)
Drug: Janagliflozin 25mg
Each patient will receive 50 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)
Drug: Janagliflozin 50mg
In the core period, each patient will receive placebo once daily for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin once daily until Week 52.
Drug: Placebo/Janagliflozin
Tablets, Oral, 25 mg, Tablets, Oral, 50 mg
Also known as: Placebo 50mg
Tablets, Oral, 25 mg, Once daily, 52 weeks
Also known as: Placebo 25mg
Tablets, Oral, 25 mg, Once daily, 52 weeks
Change 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
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
Urinary albumin/creatinine ratio (UACR)
To evaluate Urinary albumin/creatinine ratio in different group
Time frame: From Baseline to Week 52
Occurrence of adverse events
To evaluate adverse events in different group
Time frame: From Baseline to Week 52
Occurrence of hypoglycaemic episodes
To evaluate adverse events in different group
Time frame: From Baseline to Week 52
Population pharmacokinetics assessment
By compare patients' Minimum Plasma Concentration (on week 2, 4, 8, 24)to eveluate Janagliflozin population pharmacokinetics characteristics
Time frame: Baseline, Week 2, Week4, Week8, Week24
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Sihuan Pharmaceutical Holdings Group Ltd.