- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01919489
Liraglutide Hospital Discharge Trial
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States
- University of Miami
-
-
Georgia
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Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
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Atlanta, Georgia, United States, 30324
- Emory University Hospital
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Atlanta, Georgia, United States
- Emory Universtiy Hospital at MIdtown
-
-
New York
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New York, New York, United States
- State University of NY at Buffalo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Liraglutide + OADs
Liraglutide once daily in combination to oral anti-diabetic agents (OADs)
|
Liraglutide subcutaneously daily
Other Names:
|
ACTIVE_COMPARATOR: Glargine + OADs
Glargine once daily in combination to oral anti-diabetic agents (OADs)
|
Glargine once daily subcutaneously
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic Control at Hospital Discharge and 6 Months Follow up
Time Frame: Hospital discharge, 6 months (26 weeks)
|
To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy
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Hospital discharge, 6 months (26 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks
Time Frame: After discharge, average at 3 months (12 week) and 6 months (26 weeks)
|
To determine differences in BG concentration between liraglutide and glargine insulin therapy
|
After discharge, average at 3 months (12 week) and 6 months (26 weeks)
|
Hypoglycemic Episodes
Time Frame: After discharge, average 6 months
|
Number of participants who had at least one hypoglycemic event (<70 mg/dl) and severe hypoglycemic event (<40 mg/dl)
|
After discharge, average 6 months
|
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
|
After discharge, average 6 months
|
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
|
After discharge, average 6 months
|
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
|
After discharge, average 12 weeks
|
Change in Body Weight From Baseline
Time Frame: After discharge, average 6 months
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Change in body weight from baseline after 6 months of follow up (26 weeks)
|
After discharge, average 6 months
|
Change in BMI
Time Frame: Baseline, and follow up after discharge (average 6 months)
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Change in BMI after 6 months from baseline
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Baseline, and follow up after discharge (average 6 months)
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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
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After discharge, average 6 months
|
Change in Cardiovascular Risk Factors: Blood Pressure
Time Frame: Baseline, 26 weeks post-intervention
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Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention
|
Baseline, 26 weeks post-intervention
|
Cardiovascular Risk Factor: Heart Rate
Time Frame: 26 weeks post-intervention
|
Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention
|
26 weeks post-intervention
|
Cardiovascular Risk Factor: Lipid Profile
Time Frame: 26 weeks post-intervention
|
Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention.
This outcome was not part of standard of care.
|
26 weeks post-intervention
|
Emergency Room Visits and Readmissions
Time Frame: After discharge, average 6 months
|
Number of participants who had at least one emergency room visit and hospital readmissions
|
After discharge, average 6 months
|
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)
|
After discharge, average 6 months
|
Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up
Time Frame: 26 weeks post-intervention
|
Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up
|
26 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00068128
- (UTN) U1111-1139-2991 (REGISTRY: UNIVERSAL TRIAL NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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