Liraglutide Hospital Discharge Trial

NCT ID: NCT01919489

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2020-08-30

Brief 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.

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 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.

Conditions

Type 2 Diabetes

Keywords

Incretins; Liraglutide; Glargine; Randomized controlled trial; basal insulin; hospital discharge; inpatient diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liraglutide + OADs

Liraglutide once daily in combination to oral anti-diabetic agents (OADs)

Group Type: EXPERIMENTAL

Liraglutide + OADs

Intervention Type: DRUG

Liraglutide subcutaneously daily

Glargine + OADs

Glargine once daily in combination to oral anti-diabetic agents (OADs)

Group Type: ACTIVE_COMPARATOR

Glargine + OADs

Intervention Type: DRUG

Glargine once daily subcutaneously

Interventions

Liraglutide + OADs

Liraglutide subcutaneously daily

Intervention Type: DRUG

Glargine + OADs

Glargine once daily subcutaneously

Intervention Type: DRUG

Other Intervention Names

Victoza® + OADs; Glargine (Lantus®) + OADs

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo E Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University SOM

Locations

University of Miami

Miami, Florida, United States

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Emory Universtiy Hospital at MIdtown

Atlanta, Georgia, United States

State University of NY at Buffalo

New York, New York, United States

Countries

Spain; United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

(UTN) U1111-1139-2991

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB00068128

Identifier Type: -

Identifier Source: org_study_id