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Clinical Trial Details

Trial ID: L5756
Source ID: NCT03359837
Associated Drug: Insulin Glargine (Hoe901)
Title: Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
Acronym: SWITCH
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: INSULIN GLARGINE (HOE901)|DRUG: Insulin Glulisine|DRUG: Biphasic insulin aspart 30|DRUG: Repaglinide|DRUG: Acarbose|DRUG: Metformin
Outcome Measures: Primary: Change in hemoglobin A1c (HbA1c), Change in HbA1c from baseline to week 24, Baseline to Week 24 | Secondary: Patients with fasting plasma glucose (FPG) <6.1 mmol/L, Percentage of patients with FPG \<6.1 mmol/L at week 12 and week 24, At Week 12 and Week 24|Patients with FPG <6.1 mmol/L without hypoglycemia, Percentage of patients with FPG \<6.1 mmol/L without hypoglycemia at week 12 and week 24, At Week 12 and Week 24|Patients with FPG <7 mmol/L, Percentage of patients with FPG \<7 mmol/L at week 12 and week 2, At Week 12 and Week 24|Patients with FPG <7 mmol/L without hypoglycemia, Percentage of patients with FPG \<7 mmol/L without hypoglycemia at week 12 and week 24, At Week 12 and Week 24|Patients with HbA1c <7%, Percentage of patients with HbA1c \<7% at week 12 and week 24, At Week 12 and Week 24|Patients with HbA1c <7% without hypoglycemia, Percentage of patients with HbA1c \<7% without hypoglycemia at week 12 and week 24, At Week 12 and Week 24|Hypoglycemic events, Incidence of hypoglycemia during treatment period, Baseline to Week 24|Change in FPG, Change in FPG from baseline to week 24, Baseline to Week 24|Change in body weight, Change in body weight from baseline to week 24, Baseline to Week 24|Insulin dose, Total daily insulin dose at week 24, At Week 24|Daily BG variation at week 24, Daily blood glucose (BG) variation at week 24, At Week 24|European quality of life - 5 dimensions (EQ-5D), Change in quality of life scores from baseline to week 24 on 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured at 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problem., Baseline to Week 24|Subgroup analysis, Subgroup analysis of control rate of HbA1c \<7% according to duration of diabetes, oral anti-hyperglycemic drug(OAD) treatment and HbA1c at screening, FPG, post prandial glucose(PPG) excursion and C peptide at the beginning of run-in period, insulin dose at end of run-in period, At week 24
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 384
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-01-20
Completion Date: 2020-06-29
Results First Posted:
Last Update Posted: 2022-04-25
Locations: CHINA, China, China
URL: https://clinicaltrials.gov/show/NCT03359837