Liraglutide Hospital Discharge Trial

Condition(s) targeted: Type 2 Diabetes

Intervention: Liraglutide + OADs (Drug); Glargine + OADs (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Guillermo E Umpierrez, MD, Principal Investigator, Affiliation: Emory University SOM

Overall contact:
Guillermo E Umpierrez, MD, Phone: 404-778-1665, Email: geumpie@emory.edu

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Glycemic control

Secondary outcome:

Fasting and postprandial blood glucose (BG) concentration

Hypoglycemic episodes

HbA1c <7.0% and no hypoglycemia

HbA1c <7.0% and no weight gain

HbA1c <7.0% and no hypoglycemia

Change in body weight and BMI

Total daily dose of insulin

Cardiovascular risk factors

Emergency room visits and readmissions

Acute renal failure

Detailed description: 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 non-surgical patients with T2D after hospital discharge. Patients with poorly controlled (HbA1c >7%-10%) T2D treated with diet or oral antidiabetic agents (insulin naïve) prior to admission will be randomized to liraglutide and glargine in combination to OADs at hospital discharge.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Males or females between the ages of 18 and 80 years discharged after hospital admission from general medicine services (non-surgical and non-ICU setting). 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 increased BG concentration, but without a history of diabetes (stress hyperglycemia) 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 study. 13. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice).

Guillermo E Umpierrez, MD, Phone: 404-778-1665, Email: geumpie@emory.edu

Hospital de la Santa Creu i Sant Pau, Barcelona 08026, Spain; Not yet recruiting
Antonio Perez-Perez, MD, Email: APerez@santpau.cat
Antonio Perez-Perez, MD, Principal Investigator

Hospital Universitario Insular, Las Palmas de Gran Canaria 35016, Spain; Not yet recruiting
Francisco J Novoa, MD, Email: fnovoa@dcmq.ulpgc.es
Francisco J Novoa, MD, Principal Investigator

Hospital Clínico de Madrid, Madrid 28040, Spain; Not yet recruiting
Alfonso Calle, MD, Email: acalle.edu@gmail.com
Alfonso Calle, MD, Principal Investigator

Hospital General Carlos Haya, Malaga 29010, Spain; Not yet recruiting
Ricardo Gomez-Huelgas, MD, Email: ricardogomezhuelgas@hotmail.com
Ricardo Gomez-Huelgas, MD, Principal Investigator

Hospital General de Segovia, Segovia 40002, Spain; Not yet recruiting
Fernando Gomez-Peralta, MD, Email: Fernando Gomez Peralta
Fernando Gomez-Peralta, MD, Principal Investigator

Emory University Hospital, Atlanta, Georgia 30324, United States; Recruiting
Dawn Smiley-Byrd, MD, Email: dsmiley@emory.edu
Dawn Smiley-Byrd, MD, Sub-Investigator

Grady Memorial Hospital, Atlanta, Georgia 30303, United States; Recruiting
Guillermo E Umpierrez, MD, Phone: 404-778-1665, Email: geumpie@emory.edu
Francisco J Pasquel, MD, Phone: 404 778 1697, Email: fpasque@emory.edu
Guillermo Umpierrez, MD, Principal Investigator
Francisco J Pasquel, MD, Sub-Investigator
Dawn Smiley, MD, Sub-Investigator
Priya Vellanki, MD, Sub-Investigator

Starting date: March 2014
Last updated: March 6, 2015