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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Janagliflozin 25mg | Experimental | Each patient will receive 25 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period) |
|
| Janagliflozin 50mg | Experimental | Each patient will receive 50 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period) |
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| Placebo/Janagliflozin | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Janagliflozin 25mg | Drug | Tablets, Oral, 25 mg, Tablets, Oral, 50 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 52 | To compare the mean change in HbA1c from baseline to week 52 between groups | Baseline and Week 52 |
| Percentage of Patients With HbA1c <7% at Week 24 (Core period) and week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary albumin/creatinine ratio (UACR) | To evaluate Urinary albumin/creatinine ratio in different group | From Baseline to Week 52 |
| Occurrence of adverse events | To evaluate adverse events in different group |
Inclusion Criteria:
Exclusion Criteria:
History of type 1 diabetes mellitus (T1DM), diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by Cushing's syndrome or acromegaly)
More than 10% change in body weight within the 3 months before screening
Any laboratory test indicators meet the following standards:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leili Gao, Doctor | Contact | 00861088325578 | 00861088324516 | plum_jj@sina.com |
| Linong Ji, Doctor | Contact | 00861088325578 | 00861088324516 | jiln@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linong Ji | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000727437 | janagliflozin |
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Double Blind
| Janagliflozin 50mg | Drug | Tablets, Oral, 25 mg, Once daily, 52 weeks |
|
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| Placebo/Janagliflozin | Drug | Tablets, Oral, 25 mg, Once daily, 52 weeks |
|
To compare the percentage of patients with HbA1c <7% at week 24 (core period) and week 52 (extension period) between groups
| 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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. | 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 | Week 24 and Week 52 |
| From Baseline to Week 52 |
| Occurrence of hypoglycaemic episodes | To evaluate adverse events in different group | 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 | Baseline, Week 2, Week4, Week8, Week24 |
| D004700 | Endocrine System Diseases |