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Clinical Trial Details

Trial ID: L7374
Source ID: NCT05002933
Associated Drug: Insulin Glargine 300 U/Ml
Title: A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period
Acronym: INITIATION
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin glargine 300 U/ml
Outcome Measures: Primary: Mean change in HbA1c from baseline to week 24, Baseline to Week 24 | Secondary: Mean change in HbA1c from baseline to week 12 and week 36, Baseline to Week 12 and 36|Percentage of participants achieving HbA1c target <7%, at Week 12, 24 and 36|Percentage of participants achieving HbA1c target <7% without hypoglycemic events, at Week 12 and 24|Mean change in Fasting Plasma Glucose (FPG) from baseline to week 12, 24 and 36, Baseline to Week 12, 24 and 36|Mean change in fasting Self-Monitored Blood Glucose (SMBG) from baseline to week 12 and week 24, Baseline to Week 12 and 24|Mean change in of 7-points SMBG per time point from baseline to week 12 and week 24, Baseline to Week 12 and 24|Mean change in Insulin glargine U300 dose from baseline to week 12, 24 and 36, Baseline to Week 12, 24 and 36|Number of participants experiencing hypoglycemia from baseline to week 12, 24 and 36, Baseline to Week 12, 24 and 36|Number of hypoglycemic events per patient-year, Baseline to Week 12, 24 and 36|Number of participants with adverse events, Baseline to Week 24 and 36|Mean change in body weight from baseline to Week 12 and Week 24, Baseline to Week 12 and 24
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 570
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-20
Completion Date: 2023-02-24
Results First Posted:
Last Update Posted: 2023-03-09
Locations: Investigational Sites, China, China
URL: https://clinicaltrials.gov/show/NCT05002933