Liraglutide Hospital Discharge Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01919489
First received: July 30, 2013
Last updated: July 2, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes
Drug: Liraglutide + OADs
Drug: Glargine + OADs
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: After discharge, 6 months ] [ Designated as safety issue: No ]
    To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy


Secondary Outcome Measures:
  • Fasting and postprandial blood glucose (BG) concentration [ Time Frame: After discharge, average 6 months ] [ Designated as safety issue: No ]
    To determine differences in BG concentration between liraglutide and glargine insulin therapy

  • Hypoglycemic episodes [ Time Frame: After discharge, average 6 months ] [ Designated as safety issue: Yes ]
    Number of hypoglycemic events (<70 mg/dl) and severe hypoglycemic events (<40 mg/dl)

  • HbA1c <7.0% and no hypoglycemia [ Time Frame: After discharge, average 6 months ] [ Designated as safety issue: Yes ]
    Percent of patients with 26 week HbA1c <7.0% and no hypoglycemia

  • HbA1c <7.0% and no weight gain [ Time Frame: After discharge, average 6 months ] [ Designated as safety issue: No ]
    Percent of patients with 26 week HbA1c <7.0% and no weight gain

  • HbA1c <7.0% and no hypoglycemia [ Time Frame: After discharge, average 12 weeks ] [ Designated as safety issue: Yes ]
    Percent of patients with 12 week HbA1c <7.0% and no hypoglycemia

  • Change in body weight and BMI [ Time Frame: After discharge, average 6 months ] [ Designated as safety issue: No ]
    Change in body weight and BMI after 6 months

  • Total daily dose of insulin [ Time Frame: After discharge, average 6 months ] [ Designated as safety issue: No ]
    Evaluate the total daily dose of insulin needed in the group receiving glargine

  • Cardiovascular risk factors [ Time Frame: After discharge, average 6 months ] [ Designated as safety issue: Yes ]
    Cardiovascular risk factors including changes in blood pressure, heart rate, and lipid profile

  • Emergency room visits and readmissions [ Time Frame: After discharge, average 6 months ] [ Designated as safety issue: Yes ]
    Number of emergency room visits and hospital readmissions

  • Acute renal failure [ Time Frame: After discharge, average 6 months ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 280
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (metformin, sulfonylureas, repaglinide, nateglinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, pioglitazone) as monotherapy or in combination therapy (excluding GLP-1 receptor agonists) 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919489

Contacts
Contact: Guillermo E Umpierrez, MD 404-778-1665 geumpie@emory.edu
Contact: Francisco J Pasquel, MD 404 778 1697 fpasque@emory.edu

Locations
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Guillermo E Umpierrez, MD    404-778-1665    geumpie@emory.edu   
Contact: Francisco J Pasquel, MD    404 778 1697    fpasque@emory.edu   
Principal Investigator: Guillermo Umpierrez, MD         
Sub-Investigator: Francisco J Pasquel, MD         
Sub-Investigator: Dawn Smiley, MD         
Sub-Investigator: Priya Vellanki, MD         
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30324
Contact: Dawn Smiley-Byrd, MD       dsmiley@emory.edu   
Sub-Investigator: Dawn Smiley-Byrd, MD         
Spain
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain, 08026
Contact: Antonio Perez-Perez, MD       APerez@santpau.cat   
Principal Investigator: Antonio Perez-Perez, MD         
Hospital Universitario Insular Not yet recruiting
Las Palmas de Gran Canaria, Spain, 35016
Contact: Francisco J Novoa, MD       fnovoa@dcmq.ulpgc.es   
Principal Investigator: Francisco J Novoa, MD         
Hospital Clínico de Madrid Not yet recruiting
Madrid, Spain, 28040
Contact: Alfonso Calle, MD       acalle.edu@gmail.com   
Principal Investigator: Alfonso Calle, MD         
Hospital General Carlos Haya Not yet recruiting
Malaga, Spain, 29010
Contact: Ricardo Gomez-Huelgas, MD       ricardogomezhuelgas@hotmail.com   
Principal Investigator: Ricardo Gomez-Huelgas, MD         
Hospital General de Segovia Not yet recruiting
Segovia, Spain, 40002
Contact: Fernando Gomez-Peralta, MD       Fernando Gomez Peralta <fgomezperalta@gmail.com>   
Principal Investigator: Fernando Gomez-Peralta, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Guillermo E Umpierrez, MD Emory University SOM
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01919489     History of Changes
Other Study ID Numbers: IRB00068128, (UTN) U1111-1139-2991
Study First Received: July 30, 2013
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Incretins
Liraglutide
Glargine
Randomized controlled trial
basal insulin
hospital discharge
inpatient diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014