Objective: This multicenter, double-blind, treat-to-target, phase 3 trial evaluated the efficacy and RESEARCH DESIGN AND METHODS: The primary end point was HbA change from baseline after 26 weeks' treatment. After an 8-week run-in to optimize basal insulin, subjects were randomized (1:1) to mealtime faster aspart ( = 345) or IAsp ( = 344), titrated using a simple daily patient-driven algorithm, plus insulin glargine U100 and metformin.
Results: HbA change was -1.
Objective: This meta-analysis of 5 trials from the Phase 3a insulin degludec (IDeg) clinical trial program evaluated the risk of hypoglycemia in a subset of subjects with type 2 diabetes (T2D) who required high basal insulin doses at the end of the trials.
Methods: This meta-analysis compared glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), basal insulin dose, body weight, and rates of overall and nocturnal confirmed hypoglycemia in a pooled population of T2D subjects using >60 U basal insulin at trial completion. Five Phase 3a, open-label, randomized, treat-to-target, confirmatory 26- or 52-week trials with IDeg (n = 2,262) versus insulin glargine (IGlar) (n = 1,110) administered once daily were included.
Background: Pregnant women are at an increased risk of venous thromboembolism (VTE). Risk factors for VTE among pregnant women are not sufficiently investigated.
Purpose: To examine pharmacological and non-pharmacological VTE risk factors during pregnancy (antepartum).
Objectives: Our aim was to assess the association between use of hormone replacement therapy (HRT) and risk of new-onset atrial fibrillation (AF) after myocardial infarction.
Design, Setting And Participants: We used Danish nationwide registers of hospitalizations and prescriptions to identify all women admitted with myocardial infarction in the period 1997 to 2009 and with no known diagnosis of AF. Their use of overall HRT and HRT categories was assessed.
Objective: To assess the risk of adverse cardiovascular events in women who discontinue hormone replacement therapy after myocardial infarction compared with those who continue.
Design: Nationwide register based cohort study.
Setting: All hospitals in Denmark.