Liraglutide Hospital Discharge Trial

NCT01919489 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB00068128(UTN) U1111-1139-2991
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 5

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.

Conditions

Type 2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Glycemic Control at Hospital Discharge and 6 Months Follow up

  To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy

  Hospital discharge, 6 months (26 weeks)

Secondary Outcomes (14)

• Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks

  After discharge, average at 3 months (12 week) and 6 months (26 weeks)

• Hypoglycemic Episodes

  After discharge, average 6 months

• HbA1c <7.0% and no Hypoglycemia

  After discharge, average 6 months

• HbA1c <7.0% and no Weight Gain

  After discharge, average 6 months

• HbA1c <7.0% and no Hypoglycemia

  After discharge, average 12 weeks

Study Arms (2)

Liraglutide + OADs

EXPERIMENTAL

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

Drug: Liraglutide + OADs

Glargine + OADs

ACTIVE COMPARATOR

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

Drug: Glargine + OADs

Interventions

Liraglutide + OADs DRUG

Liraglutide subcutaneously daily

Also known as: Victoza® + OADs

Liraglutide + OADs

Glargine + OADs DRUG

Glargine once daily subcutaneously

Also known as: Glargine (Lantus®) + OADs

Glargine + OADs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Admission HbA1c between 7% and 10%
• 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.
• 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).
• BMI \> 25 Kg/m2 and ≤ 45 Kg/m2

You may not qualify if:

• Age \< 18 or \> 80 years.
• Subjects with stress hyperglycemia (BG \> 140 mg/dL and HbA1c \< 6.5%)
• Subjects with a history of type 1 diabetes
• Treatment with insulin or GLP-1 analogs during the past 3 months prior to admission.
• Recurrent severe hypoglycemia or hypoglycemic unawareness.
• Subjects with gastrointestinal obstruction, gastroparesis, or those expected to require gastrointestinal suction.
• History of medullary thyroid cancer or multiple endocrine neoplasias
• Patients with acute or chronic pancreatitis, pancreatic cancer, or gallbladder disease.
• 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).
• Treatment with oral or injectable corticosteroid (equivalent or higher than prednisone 5mg/day), parenteral nutrition, and immunosuppressive treatment.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Female subjects who are pregnant or breastfeeding at the time of enrollment into the study.
• Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice).

Sponsors & Collaborators

• Emory University: lead
• Novo Nordisk A/S: collaborator

Study Sites (5)

University of Miami

Miami, Florida, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital

Atlanta, Georgia, 30324, United States

Location

Emory Universtiy Hospital at MIdtown

Atlanta, Georgia, United States

Location

State University of NY at Buffalo

New York, New York, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Liraglutide; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Francisco Pasquel
• Organization: Emory University

fpasque@emory.edu

404-778-1695

Study Officials

• Guillermo E Umpierrez, MD

  Emory University SOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 9, 2013
• Study Start: March 1, 2014
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2021-08

Locations

US (5)