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Liraglutide Hospital Discharge Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01919489
Recruitment Status : Suspended (Recruitment is suspended due to COVID-19. Study visits for currently enrolled subjects are ongoing per an IRB approved amendment to reflect the pandemic status)
First Posted : August 9, 2013
Last Update Posted : May 4, 2020
Novo Nordisk A/S
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Liraglutide + OADs Drug: Glargine + OADs Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Liraglutide + OADs
Liraglutide once daily in combination to oral anti-diabetic agents (OADs)
Drug: Liraglutide + OADs
Liraglutide subcutaneously daily
Other Name: Victoza® + OADs

Active Comparator: Glargine + OADs
Glargine once daily in combination to oral anti-diabetic agents (OADs)
Drug: Glargine + OADs
Glargine once daily subcutaneously
Other Name: Glargine (Lantus®) + OADs

Primary Outcome Measures :
  1. Glycemic control [ Time Frame: After discharge, 6 months ]
    To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy

Secondary Outcome Measures :
  1. Fasting and postprandial blood glucose (BG) concentration [ Time Frame: After discharge, average 6 months ]
    To determine differences in BG concentration between liraglutide and glargine insulin therapy

  2. Hypoglycemic episodes [ Time Frame: After discharge, average 6 months ]
    Number of hypoglycemic events (<70 mg/dl) and severe hypoglycemic events (<40 mg/dl)

  3. HbA1c <7.0% and no hypoglycemia [ Time Frame: After discharge, average 6 months ]
    Percent of patients with 26 week HbA1c <7.0% and no hypoglycemia

  4. HbA1c <7.0% and no weight gain [ Time Frame: After discharge, average 6 months ]
    Percent of patients with 26 week HbA1c <7.0% and no weight gain

  5. HbA1c <7.0% and no hypoglycemia [ Time Frame: After discharge, average 12 weeks ]
    Percent of patients with 12 week HbA1c <7.0% and no hypoglycemia

  6. Change in body weight and BMI [ Time Frame: After discharge, average 6 months ]
    Change in body weight and BMI after 6 months

  7. Total daily dose of insulin [ Time Frame: After discharge, average 6 months ]
    Evaluate the total daily dose of insulin needed in the group receiving glargine

  8. Cardiovascular risk factors [ Time Frame: After discharge, average 6 months ]
    Cardiovascular risk factors including changes in blood pressure, heart rate, and lipid profile

  9. Emergency room visits and readmissions [ Time Frame: After discharge, average 6 months ]
    Number of emergency room visits and hospital readmissions

  10. Acute renal failure [ Time Frame: After discharge, average 6 months ]
    Acute renal failure during the 26-week follow-up defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment in creatinine > 0.5 mg/dL from baseline)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01919489

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United States, Florida
University of Miami
Miami, Florida, United States
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Emory University Hospital
Atlanta, Georgia, United States, 30324
Emory Universtiy Hospital at MIdtown
Atlanta, Georgia, United States
United States, New York
State University of NY at Buffalo
New York, New York, United States
Sponsors and Collaborators
Emory University
Novo Nordisk A/S
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Principal Investigator: Guillermo E Umpierrez, MD Emory University SOM
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Responsible Party: Guillermo Umpierrez, MD, Professor of Medicine, Emory University Identifier: NCT01919489    
Other Study ID Numbers: IRB00068128
(UTN) U1111-1139-2991 ( Registry Identifier: UNIVERSAL TRIAL NUMBER )
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Keywords provided by Guillermo Umpierrez, MD, Emory University:
Randomized controlled trial
basal insulin
hospital discharge
inpatient diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists