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Clinical Trial Details

Trial ID: L2819
Source ID: NCT02836704
Associated Drug: Insulin Glargine
Title: Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: INSULIN GLARGINE|DRUG: metformin|DRUG: acarbose
Outcome Measures: Primary: Percentage of patients with at least one episode of hypoglycemia, 16 weeks | Secondary: Percentage of patients achieving HbA1c <7%, 16 weeks|Percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L), 16 weeks|Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L), 16 weeks|Change from baseline in HbA1c, Baseline, 16 weeks|Change from baseline in Fasting Plasma Glucose, Baseline, 16 weeks|Change from baseline in Post Prandial Glucose, Baseline, 16 weeks|Change in body weight, Baseline, 16 weeks|- Change in insulin dose, Baseline, 16 weeks|Number of overall hypoglycemic events (with severe or confirmed hypoglycemia [≤3.9 mmol/L]), Baseline, 16 weeks|Number of nocturnal hypoglycemic events, Baseline, 16 weeks|Number of severe hypoglycemic events, Baseline, 16 weeks
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 892
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-09-09
Completion Date: 2018-04-26
Results First Posted:
Last Update Posted: 2022-04-25
Locations: China, China
URL: https://clinicaltrials.gov/show/NCT02836704