The effect of baseline characteristics on clinical efficacy of liraglutide in patients treated with high‐dose insulin

In patients requiring high‐dose insulin treatment, a randomized, double‐blind, placebo‐controlled study showed that liraglutide improved glycaemic control and treatment satisfaction while promoting weight loss. We performed a post hoc analysis to evaluate if patients’ baseline characteristics impact the efficacy of liraglutide, and which outcomes correlate with treatment satisfaction. We used regression analysis to model the change in HbA1c and weight, with treatment assignment and baseline characteristics [HbA1c, age, body mass index (BMI), total daily dose (TDD) of insulin, duration of insulin treatment, and type of insulin regimen] as independent variables. Improvement in HbA1c was best predicted by treatment with liraglutide, followed by higher baseline HbA1c, BMI and age. Changes in weight were only associated with liraglutide treatment, independent of all baseline characteristics. Improvement in HbA1c was the only significant predictor of improvement in treatment satisfaction, while weight loss, change in TDD of insulin and rate of hypoglycaemia did not influence treatment satisfaction. In patients treated with high‐dose insulin, liraglutide significantly improved glycaemic control and led to weight loss regardless of patients’ baseline characteristics. Improvement in HbA1c was the most important predictor of patients’ treatment satisfaction.

[1]  B. Adams-Huet,et al.  Effect of Adding Liraglutide vs Placebo to a High-Dose lnsulin Regimen in Patients With Type 2 Diabetes: A Randomized Clinical Trial. , 2016, JAMA internal medicine.

[2]  B. Wolffenbuttel,et al.  Relationship of body mass index with efficacy of exenatide twice daily added to insulin glargine in patients with type 2 diabetes , 2016, Diabetes, obesity & metabolism.

[3]  Laurentiu M. Pop,et al.  Mechanisms of Action of Liraglutide in Patients With Type 2 Diabetes Treated With High-Dose Insulin. , 2016, The Journal of clinical endocrinology and metabolism.

[4]  S. Colagiuri,et al.  Improvement in glycated haemoglobin evaluated by baseline body mass index: a meta‐analysis of the liraglutide phase III clinical trial programme , 2016, Diabetes, obesity & metabolism.

[5]  M. Ganz,et al.  Clinical Effectiveness of Liraglutide Across Body Mass Index in Patients with Type 2 Diabetes in the United States: A Retrospective Cohort Study , 2014, Advances in Therapy.

[6]  W. Lane,et al.  The effect of addition of liraglutide to high‐dose intensive insulin therapy: a randomized prospective trial , 2014, Diabetes, obesity & metabolism.

[7]  B. Hoogwerf,et al.  Baseline Factors Associated With Glycemic Control and Weight Loss When Exenatide Twice Daily Is Added to Optimized Insulin Glargine in Patients With Type 2 Diabetes , 2012, Diabetes Care.

[8]  M. Davies,et al.  Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. , 2011, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[9]  P. Raskin,et al.  Insulin-Based Versus Triple Oral Therapy for Newly Diagnosed Type 2 Diabetes , 2009, Diabetes Care.

[10]  I. Hirsch,et al.  High-dose insulin therapy: is it time for U-500 insulin? , 2009, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[11]  M. Funnell Quality of Life and Insulin Therapy in Type 2 Diabetes Mellitus , 2008 .

[12]  M. Koopmanschap,et al.  Health-related quality of life and treatment satisfaction in Dutch patients with type 2 diabetes. , 2002, Diabetes care.

[13]  G. Brown,et al.  Quality of life associated with diabetes mellitus in an adult population. , 2000, Journal of diabetes and its complications.