Liraglutide Hospital Discharge Trial
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Liraglutide + OADs; Glargine + OADs
Intervention description: Liraglutide subcutaneously daily; Glargine once daily subcutaneously
Intervention MeSH terms: Insulin Glargine; Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Incretins; Liraglutide; Glargine; Randomized controlled trial; basal insulin; hospital discharge; inpatient diabetes

Summary:

      High blood glucose levels in hospitalized patients with diabetes are associated with
      increased risk of medical complications and death. Improved glucose control with insulin
      injections may improve clinical outcome and prevent some of the hospital complications.
      Increasing evidence indicates that incretin-based agents are safe and effective for the
      hospital management of patients with type 2 diabetes (T2D).

      Liraglutide is a once-daily human glucagon-like peptide (GLP-1) analogue approved for the
      treatment of T2D. Liraglutide has been shown to lower blood glucose, stimulate endogenous
      insulin secretion, decrease plasma glucagon levels, inhibit gastric emptying, reduce food
      intake and body weight and improve ß-cell function when administered subcutaneously.
      Liraglutide increases insulin secretion in a glucose-dependent manner (i.e., only when plasma
      glucose levels are elevated), resulting in low-risk of hypoglycemia when used as monotherapy.
      When compared to insulin glargine therapy, the use of GLP-1 has resulted in comparable
      reduction in HbA1c level, lower rates of hypoglycemia and less weight gain. No prospective
      studies; however, have compared the efficacy and safety of liraglutide in the hospital
      setting or after hospital discharge.

      The primary objective is to compare the safety and efficacy of liraglutide (Victoza®) versus
      glargine insulin in combination to oral anti-diabetic agents (OADs: metformin, sulfonylureas,
      nateglinide, repaglinide or pioglitazone) on glycemic control after 26 weeks of treatment in
      medicine patients with T2D after hospital discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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).

          2. Admission HbA1c between 7% and 10%

          3. 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.

          4. 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).

          5. BMI > 25 Kg/m2 and ≤ 45 Kg/m2

        Exclusion Criteria:

          1. Age < 18 or > 80 years.

          2. Subjects with stress hyperglycemia (BG > 140 mg/dL and HbA1c < 6.5%)

          3. Subjects with a history of type 1 diabetes

          4. Treatment with insulin or GLP-1 analogs during the past 3 months prior to admission.

          5. Recurrent severe hypoglycemia or hypoglycemic unawareness.

          6. Subjects with gastrointestinal obstruction, gastroparesis, or those expected to
             require gastrointestinal suction.

          7. History of medullary thyroid cancer or multiple endocrine neoplasias

          8. Patients with acute or chronic pancreatitis, pancreatic cancer, or gallbladder
             disease.

          9. 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).

         10. Treatment with oral or injectable corticosteroid (equivalent or higher than prednisone
             5mg/day), parenteral nutrition, and immunosuppressive treatment.

         11. Mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study.

         12. Female subjects who are pregnant or breastfeeding at the time of enrollment into the
             study.

         13. Females of childbearing potential who are not using adequate contraceptive methods (as
             required by local law or practice).