Liraglutide Hospital Discharge Trial

Specific Aim: To determine whether treatment with liraglutide (Victoza®) will result in similar glycemic control (HbA1c at 26 weeks) and a lower rate of hypoglycemic events compared to treatment with glargine (Lantus®) in patients with T2D after hospital discharge. Patients with poorly controlled (HbA1c >7%-10%) T2D treated with diet or oral antidiabetic agents or low dose insulin naïve (0.4u/kg/day) prior to admission will be randomized to liraglutide or glargine in combination to OADs at hospital discharge.

Inclusion criteria

• Males or females between the ages of 18 and 80 years discharged after hospital admission from non- ICU general surgery and medicine services (excluding gastrointestinal and cardiac surgeries).
• Admission HbA1c between 7% and 10%
• Patients with T2D treated with diet alone or with oral antidiabetic agents as monotherapy or in combination therapy (excluding GLP1 receptor agonists) or on low-dose insulin therapy (TDD ≤0.4 unit/kg/day) prior to admission.
• Subjects with a hospital admission BG < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
• BMI > 25 Kg/m2 and ≤ 45 Kg/m2

Exclusion criteria

• Age < 18 or > 80 years.
• Subjects with stress hyperglycemia (BG > 140 mg/dL and HbA1c < 6.5%)
• Subjects with a history of type 1 diabetes
• Treatment with insulin or GLP-1 analogs during the past 3 months prior to admission.
• Recurrent severe hypoglycemia or hypoglycemic unawareness.
• Subjects with gastrointestinal obstruction, gastroparesis, or those expected to require gastrointestinal suction.
• History of medullary thyroid cancer or multiple endocrine neoplasias
• Patients with acute or chronic pancreatitis, pancreatic cancer, or gallbladder disease.
• Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 30 ml/min).
• Treatment with oral or injectable corticosteroid (equivalent or higher than prednisone 5mg/day), parenteral nutrition, and immunosuppressive treatment.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Female subjects who are pregnant or breastfeeding at the time of enrollment into the study.
• Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice).