Liraglutide Hospital Discharge Trial

Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Age Range:18 - 80
Start Date:March 2014
End Date:December 2019
Contact:Guillermo E Umpierrez, MD

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A Randomized Controlled Trial Comparing the Safety and Efficacy of Liraglutide Versus Glargine Insulin for the Management of Patients With Type 2 Diabetes After Hospital Discharge

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.

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:

1. Males or females between the ages of 18 and 80 years discharged after hospital
admission from general surgery and medicine services (non-surgical and non-ICU

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

5. BMI > 25 Kg/m2 and < 45 Kg/m2

Exclusion Criteria:

1. Age < 18 or > 80 years.

2. Subjects with increased BG concentration, but without a history of diabetes (stress

3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 Kg/m2 requiring
insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar
hyperglycemic state, or ketonuria).

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 neoplasia

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, 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 breast feeding at time of enrollment into the

13. Females of childbearing potential who are not using adequate contraceptive methods (as
required by local law or practice).
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