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Clinical Trial Details

Trial ID: L1801
Source ID: NCT03811548
Associated Drug: Janagliflozin 25mg
Title: Janagliflozin Treat T2DM Monotherapy
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Type 2
Interventions: DRUG: Janagliflozin 25mg|DRUG: Janagliflozin 50mg|DRUG: Placebo/Janagliflozin
Outcome Measures: Primary: 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 | Secondary: 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, 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 | Other: 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, 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
Sponsor/Collaborators: Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 442
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-05-23
Completion Date: 2020-12-31
Results First Posted:
Last Update Posted: 2020-07-16
Locations: Linong Ji, Beijing, Beijing, China
URL: https://clinicaltrials.gov/show/NCT03811548