Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5993
Source ID: NCT03851432
Associated Drug: Janagliflozin Plus Metformin
Title: Janagliflozin Treat Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Metformin
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Janagliflozin plus metformin|DRUG: Janagliflozin plus metformin|DEVICE: Placebo plus metformin
Outcome Measures: Primary: Change in Hemoglobin A1c (HbA1c) From Baseline to Week 24 (Core period), To examine whether the mean change in HbA1c from Baseline to Week 24 with Janagliflozin is superior 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 (Extension period), To compare the percentage of patients with HbA1c \<7% at Week 24 (core period) and Week 52 (extension period) between groups, 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) by calculation Homeostasis model assessment-insulin resistance, To compare the mean change in insulin sensitivity from Baseline to Week 24 (core period) and Week 52 (extension period) between group by calculation Homeostasis model assessment-insulin resistance, 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., Baseline, Week 24 and Week 52
Sponsor/Collaborators: Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 390
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-06-30
Completion Date: 2021-12-31
Results First Posted:
Last Update Posted: 2020-07-16
Locations: Linong Ji, Beijing, Beijing, China
URL: https://clinicaltrials.gov/show/NCT03851432