Status:
COMPLETED
Liraglutide Hospital Discharge Trial
Lead Sponsor:
Emory University
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 cli...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT01919489
Start Date
March 1 2014
End Date
August 30 2020
Last Update
November 3 2021
Active Locations (5)
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1
University of Miami
Miami, Florida, United States
2
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
3
Emory University Hospital
Atlanta, Georgia, United States, 30324
4
Emory Universtiy Hospital at MIdtown
Atlanta, Georgia, United States