Liraglutide as additional treatment in patients with Type 1 Diabetes Mellitus

DESCRIPTION (provided by applicant): The loss of beta-cell function in type 1 diabetes necessitates the use of insulin in these patients. However, a majority of such patients are not well controlled in spite of clever insulin delivering devices and continuous glucose monitoring. We, therefore, investigated the effect of liraglutide, a GLP-1 analog in combination with insulin given as a continuous subcutaneous infusion of insulin (CSII) in such patients. These patients were monitored continuously for glucose concentrations (CGM). The combination of insulin and liraglutide resulted in the reduction of fasting and mean blood glucose concentrations within 2 to 3 days with a concomitant reduction in the dose of insulin by 40%. There was a marked reduction in both hyperglycemic and hypoglycemic excursions. There was a fall in body weight, BMI, HbA1c and CRP concentrations within 9 weeks. This persisted over a period of 24 weeks. We now propose the first placebo controlled prospective, randomized study to compare the beneficial effect of liraglutide in type 1 diabetics on treatment with insulin for 56 weeks. This study will also assess whether liraglutide exerts a glucagon suppressive action post- prandially. If indeed, this study confirms a beneficial effect of liraglutide in these patients, it could becom a routine part of the treatment of type 1diabetes with marked improvements in glucose homeostasis and, therefore, a potential reduction in microvascular complications of diabetes.