Liraglutide as an Additional Treatment to Insulin in Patients with Type 1 Diabetes Mellitus—A 52-Week Randomized Double-Blinded Placebo-Controlled Clinical Trial

Abstract

We have previously demonstrated that a 12-week addition of liraglutide to insulin therapy in patients with type 1 diabetes (T1D) results in an improvement in glycemic control, weight loss and a reduction in systolic blood pressure (SBP). We have now conducted a 1 year randomized study investigating effects of liraglutide in patients with T1DM. All patients had T1D for at least one year, were on insulin therapy and had no detectable c-peptide in plasma (mean BMI: 28.9±1.4kg/m², mean HbA1c: 7.82±0.16%, mean age: 46.7±1.9 years, mean age of T1D diagnosis: 22.3±1.7 years). They were randomized to receive placebo, (n=20) or 1.8mg Liraglutide (n= 26) daily for 52 weeks. Continues glucose monitoring (CGM) was performed for 4 weeks before and at end of treatment. At the end of 52 weeks treatment with liraglutide, placebo adjusted HbA1c fell significantly by 0.57±0.17% (p=0.006 vs. placebo) from 7.920.15± to 7.45±0.12% (p=0.009). Weekly placebo adjusted average blood glucose fell by 15±4mg/dl (p=0.014 vs. placebo) from 174±5 to 156±6mg/dl (p=0.021) and fasting weekly glucose fell by 8±7mg/dl (p=0.075 vs. placebo) from 165±7 to 153±9mg/dl (p=0.032). There was no change in reported incidences of hypoglycemia and no change in percent time spent below 70mg/dl based on CGM. Total insulin dose did not alter. There was a significant weight loss by 2.5±0.9kg (placebo adjusted, p=0.041 vs. placebo) from 83.6±4.1 to 80.5±4.0kg (p=0.01) in the liraglutide group. Placebo corrected SBP also fell following liraglutide treatment by 9±3mmHg (p=0.031) from 128±3 to 122±3 mmHg while placebo adjusted diastolic BP fell by 5±1mmHg from (79±2 to 75±2mmHg). We conclude that the addition of liraglutide to insulin treatment in type 1 diabetes significantly reduced HbA1c, mean and fasting blood glucose, blood pressure and body weight without significant increase in hypoglycemia.