Clinical Trials Experience of Liraglutide in Type 2 Diabetes

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Common Adverse Reactions

The safety of Liraglutide formulation in subjects with type 2 diabetes was evaluated in 5 glycemic control, placebocontrolled trials in adults and one trial of 52 weeks duration in pediatric patients 10 years of age and older. The data in Table 1 reflect exposure of 1673 adult patients to Liraglutide formulation and a mean duration of exposure to Liraglutide formulation of 37.3 weeks. The mean age of adult patients was 58 years, 4% were 75 years or older and 54% were male. The population was 79% White, 6% Black or African American, 13% Asian; 4% were of Hispanic or Latino ethnicity. At baseline the population had diabetes for an average of 9.1 years and a mean HbA1c of 8.4%. Baseline estimated renal function was normal or mildly impaired in 88.1% and moderately impaired in 11.9% of the pooled population.

Table 1 shows common adverse reactions in adults, excluding hypoglycemia, associated with the use of Liraglutide formulation. These adverse reactions occurred more commonly on Liraglutide formulation than on placebo and occurred in at least 5% of patients treated with Liraglutide formulation. Overall, the type, and severity of adverse reactions in adolescents and children aged 10 years and above were comparable to that observed in the adult population.

In an analysis of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in Table 1.