Prospective Potential risk of No protocol available 31/12/2012 cohort trial into malignant neoplasms report) the prescribing of following treatment metformin + with combination of liraglutide in insulin detemir + combination with liraglutide + insulin as add-on metformin and the risk of neoplasms in the GPRD Protocol not available Protocol addendum available Diabetes Unexpected safety Primary objective: Q4, 2019 (LPLV) Pregnancy issues arising from To compare the proportion of Registry exposure to insulin pregnancies in pregnant detemir of pregnant An international women treated with women and the Levemir® to pregnant women safety of treated with other basal children exposed in cohort study to insulin regimens which utero evaluate the results in none of the safety of following events: treatment with Major congenital anomalies Levemir® (insulin detemir) Perinatal death in pregnant Neonatal death women with diabetes mellitus Spontaneous abortion (NN304-4016) Secondary objectives: Protocol available Multiple (see protocol) A summary Potential risk of LEADER trial analysis based on malignant neoplasms LPLV descriptive following treatment 19/01/2016 statistics will be with combination of insulin detemir + provided at the liraglutide + end of the metformin LEADER trial. (EX2211-3748) Meta analysis of Cardiovascular and Aligned with the selected clinical cerebrovascular post-approval trials events PSURs
Prospective cohort into the prescribing of metformin + liraglutide in combination with insulin as add-on and the risk of neoplasms in the GPRD Protocol not available Protocol addendum available Potential risk of malignant neoplasms following treatment with combination of insulin detemir + liraglutide + metformin No protocol available 31/12/2012 report) Diabetes Pregnancy Registry An international cohort study to evaluate the safety of treatment with Levemir® (insulin detemir) in pregnant women with diabetes mellitus (NN304-4016) Protocol available Unexpected safety issues arising from exposure to insulin detemir of pregnant women and the safety of children exposed in utero Primary objective: To compare the proportion of pregnancies in pregnant women treated with Levemir® to pregnant women treated with other basal insulin regimens which results in none of the following events: Major congenital anomalies Perinatal death Neonatal death Spontaneous abortion Secondary objectives: Multiple (see protocol) Q4, 2019 (LPLV) A summary analysis based on descriptive statistics will be provided at the end of the LEADER trial. (EX2211-3748) Potential risk of malignant neoplasms following treatment with combination of insulin detemir + liraglutide + metformin LEADER trial LPLV 19/01/2016 Meta analysis of selected clinical trials Cardiovascular and cerebrovascular events Aligned with the post-approval PSURs trial
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