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CompletedNCT01919489Updated Nov 3, 2021Results posted

Liraglutide Hospital Discharge Trial

A Phase 4 interventional study of Liraglutide + OADs and Glargine + OADs in Type 2 Diabetes, sponsored by Emory University. Completed at 5 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-03.

Sponsored by Emory University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
273
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Incretins
  • Liraglutide
  • Glargine
  • Randomized controlled trial
  • basal insulin
  • hospital discharge
  • inpatient diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 273 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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).
  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

Exclusion Criteria:

  1. Age \< 18 or > 80 years.
  2. Subjects with stress hyperglycemia (BG > 140 mg/dL and HbA1c \< 6.5%)
  3. Subjects with a history of type 1 diabetes
  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 neoplasias
  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 (equivalent or higher than prednisone 5mg/day), 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 breastfeeding at the 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).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
273 participants (actual)

Study arms

  • Experimental
    Liraglutide + OADs

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

    Drug: Liraglutide + OADs

  • Active comparator
    Glargine + OADs

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

    Drug: Glargine + OADs

Interventions

  • DrugLiraglutide + OADs

    Liraglutide subcutaneously daily

    Also known as: Victoza® + OADs

  • DrugGlargine + OADs

    Glargine once daily subcutaneously

    Also known as: Glargine (Lantus®) + OADs

06

What researchers measure

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

    Time frame: Hospital discharge, 6 months (26 weeks)

Secondary outcomes

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

    To determine differences in BG concentration between liraglutide and glargine insulin therapy

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

  2. Hypoglycemic Episodes

    Number of participants who had at least one hypoglycemic event (\<70 mg/dl) and severe hypoglycemic event (\<40 mg/dl)

    Time frame: After discharge, average 6 months

  3. HbA1c <7.0% and no Hypoglycemia

    Percent of patients with 26 week HbA1c \<7.0% and no hypoglycemia

    Time frame: After discharge, average 6 months

  4. HbA1c <7.0% and no Weight Gain

    Percent of patients with 26 week HbA1c \<7.0% and no weight gain

    Time frame: After discharge, average 6 months

  5. HbA1c <7.0% and no Hypoglycemia

    Percent of patients with 12 week HbA1c \<7.0% and no hypoglycemia

    Time frame: After discharge, average 12 weeks

  6. Change in Body Weight From Baseline

    Change in body weight from baseline after 6 months of follow up (26 weeks)

    Time frame: After discharge, average 6 months

  7. Change in BMI

    Change in BMI after 6 months from baseline

    Time frame: Baseline, and follow up after discharge (average 6 months)

  8. Total Daily Dose of Insulin

    Evaluate the total daily dose of insulin needed in the group receiving glargine

    Time frame: After discharge, average 6 months

  9. Change in Cardiovascular Risk Factors: Blood Pressure

    Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention

    Time frame: Baseline, 26 weeks post-intervention

  10. Cardiovascular Risk Factor: Heart Rate

    Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention

    Time frame: 26 weeks post-intervention

  11. Cardiovascular Risk Factor: Lipid Profile

    Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care.

    Time frame: 26 weeks post-intervention

  12. Emergency Room Visits and Readmissions

    Number of participants who had at least one emergency room visit and hospital readmissions

    Time frame: After discharge, average 6 months

  13. Acute Renal Failure

    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)

    Time frame: After discharge, average 6 months

  14. Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up

    Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up

    Time frame: 26 weeks post-intervention

07

Results

Posted Nov 3, 2021

Participant flow

Participant flow — Overall Study
MilestoneLiraglutide + OADsGlargine + OADs
Started136137
Completed8093
Not completed5644
Withdrew: Rejected the need of injections47
Withdrew: Adverse event100
Withdrew: Hospital readmission29
Withdrew: Death21
Withdrew: Lost to follow-up3827

Outcome measures

PrimaryGlycemic 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

Time frame:
Hospital discharge, 6 months (26 weeks)
Reported as:
Mean · % (mmol/mol)
Glycemic Control at Hospital Discharge and 6 Months Follow up
% (mmol/mol)Liraglutide + OADsGlargine + OADs
HbA1C at hospital discharge8.3 ± 0.98.4 ± 0.8
HbA1C at 6 months post-intervention7.13 ± 1.37.68 ± 1.69
SecondaryFasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks

To determine differences in BG concentration between liraglutide and glargine insulin therapy

Time frame:
After discharge, average at 3 months (12 week) and 6 months (26 weeks)
Reported as:
Mean · mmol/L
Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks
mmol/LLiraglutide + OADsGlargine + OADs
Fasting blood glucose at 26 weeks follow up7.61 ± 2.28.56 ± 3.8
Post-prandial blood glucose at 12 weeks7.67 ± 1.69.32 ± 8.8
Postprandial blood glucose at 26 weeks follow up8.23 ± 2.88.72 ± 2.3
Fasting blood glucose at 12 weeks7.96 ± 3.37.70 ± 2.6
SecondaryHypoglycemic Episodes

Number of participants who had at least one hypoglycemic event (\<70 mg/dl) and severe hypoglycemic event (\<40 mg/dl)

Time frame:
After discharge, average 6 months
Reported as:
Count of participants · Participants
Hypoglycemic Episodes
ParticipantsLiraglutide + OADsGlargine + OADs
Participants who had at least one hypoglycemic events (<70 mg/dl)1831
Participants who had at least one severe hypoglycemic event (<40 mg/dl)23
SecondaryHbA1c <7.0% and no Hypoglycemia

Percent of patients with 26 week HbA1c \<7.0% and no hypoglycemia

Time frame:
After discharge, average 6 months
Reported as:
Count of participants · Participants
HbA1c <7.0% and no Hypoglycemia
ParticipantsLiraglutide + OADsGlargine + OADs
HbA1c <7.0% and no Hypoglycemia3429
SecondaryHbA1c <7.0% and no Weight Gain

Percent of patients with 26 week HbA1c \<7.0% and no weight gain

Time frame:
After discharge, average 6 months
Reported as:
Count of participants · Participants
HbA1c <7.0% and no Weight Gain
ParticipantsLiraglutide + OADsGlargine + OADs
HbA1c <7.0% and no Weight Gain3221
SecondaryHbA1c <7.0% and no Hypoglycemia

Percent of patients with 12 week HbA1c \<7.0% and no hypoglycemia

Time frame:
After discharge, average 12 weeks
Reported as:
Count of participants · Participants
HbA1c <7.0% and no Hypoglycemia
ParticipantsLiraglutide + OADsGlargine + OADs
HbA1c <7.0% and no Hypoglycemia4031
SecondaryChange in Body Weight From Baseline

Change in body weight from baseline after 6 months of follow up (26 weeks)

Time frame:
After discharge, average 6 months
Reported as:
Mean · Kgs
Change in Body Weight From Baseline
KgsLiraglutide + OADsGlargine + OADs
Baseline weight at discharge101.0 ± 20.698.2 ± 18.0
Weight at six months97.2 ± 19.998.3 ± 22.1
Weight change from baseline (discharge) to 6 months after discharge-4.77 ± 80.6 ± 11
SecondaryChange in BMI

Change in BMI after 6 months from baseline

Time frame:
Baseline, and follow up after discharge (average 6 months)
Reported as:
Mean · kg/m2
Change in BMI
kg/m2Liraglutide + OADsGlargine + OADs
Baseline BMI33.5 ± 5.333.3 ± 5.3
BMI at 26 weeks follow up32.7 ± 6.833.3 ± 6.2
SecondaryTotal Daily Dose of Insulin

Evaluate the total daily dose of insulin needed in the group receiving glargine

Time frame:
After discharge, average 6 months
Reported as:
Mean · IU per day
Total Daily Dose of Insulin
IU per dayLiraglutide + OADsGlargine + OADs
Total Daily Dose of Insulin0 ± 020.9 ± 11.1
SecondaryChange in Cardiovascular Risk Factors: Blood Pressure

Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention

Time frame:
Baseline, 26 weeks post-intervention
Reported as:
Mean · mmHg
Change in Cardiovascular Risk Factors: Blood Pressure
mmHgLiraglutide + OADsGlargine + OADs
Systolic blood pressure at baseline134 ± 17130 ± 17
Systolic blood pressure at 26 weeks follow up136 ± 22135 ± 19
Diastolic blood pressure at baseline79 ± 1177 ± 12
Diastolic blood pressure at 26 weeks follow up80 ± 1379 ± 14
SecondaryCardiovascular Risk Factor: Heart Rate

Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention

Time frame:
26 weeks post-intervention
Reported as:
Mean · beats/min
Cardiovascular Risk Factor: Heart Rate
beats/minLiraglutide + OADsGlargine + OADs
Heart rate at baseline (discharge)79 ± 1479 ± 14
Heart rate at 6 months post-discharge83 ± 1379 ± 14
SecondaryCardiovascular Risk Factor: Lipid Profile

Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care.

Time frame:
26 weeks post-intervention
Reported as:
Mean · mg/dL
Cardiovascular Risk Factor: Lipid Profile
mg/dLLiraglutide + OADsGlargine + OADs
Cardiovascular Risk Factor: Lipid Profile190 ± 6130 ± 56
SecondaryEmergency Room Visits and Readmissions

Number of participants who had at least one emergency room visit and hospital readmissions

Time frame:
After discharge, average 6 months
Reported as:
Count of participants · Participants
Emergency Room Visits and Readmissions
ParticipantsLiraglutide + OADsGlargine + OADs
Number of participants with at least one ER visit3123
Number of participants with at least one hospital readmission3543
SecondaryAcute Renal Failure

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)

Time frame:
After discharge, average 6 months
Reported as:
Count of participants · Participants
Acute Renal Failure
ParticipantsLiraglutide + OADsGlargine + OADs
Acute Renal Failure13
SecondarySelf-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up

Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up

Time frame:
26 weeks post-intervention
Reported as:
Count of participants · Participants
Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up
ParticipantsLiraglutide + OADsGlargine + OADs
Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up3434

Adverse events

Collected over Data collected during follow up (6 months post-intervention).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Liraglutide + OADs2/136 (1.5%)52/136 (38.2%)0/136 (0%)
Glargine + OADs1/137 (0.7%)54/137 (39.4%)0/137 (0%)
Most frequent serious events
Most frequent serious events
EventLiraglutide + OADsGlargine + OADs
ReadmissionsGeneral disorders35/13643/137
NauseaGastrointestinal disorders37/1363/137
VomitingGastrointestinal disorders18/1360/137
Medication discontinued due to AEsGeneral disorders13/1360/137
Congestive heart failureCardiac disorders12/13613/137
Cerebrovascular eventNervous system disorders0/1363/137
Acute kidney injuryRenal and urinary disorders1/1363/137
Acute myocardial infarctionCardiac disorders0/1361/137

Baseline characteristics

Age, Continuous
Age, Continuous(years)Liraglutide + OADsGlargine + OADsTotal
Mean56.1 ± 9.555.9 ± 11.256.1 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)Liraglutide + OADsGlargine + OADsTotal
Female4761108
Male8976165
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Liraglutide + OADsGlargine + OADsTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American9795192
White232750
More than one race000
Unknown or Not Reported161531
Region of Enrollment
Region of Enrollment(participants)Liraglutide + OADsGlargine + OADsTotal
United States133134267
Argentina336
08

Study locations

5 sites
  • University of Miami
    Miami, Florida, United States
  • Grady Memorial Hospital
    Atlanta, Georgia 30303, United States
  • Emory University Hospital
    Atlanta, Georgia 30324, United States
  • Emory Universtiy Hospital at MIdtown
    Atlanta, Georgia, United States
  • State University of NY at Buffalo
    New York, New York, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 28, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01919489
Lead sponsor
Emory University
Collaborators
Novo Nordisk A/S
Responsible party
Guillermo Umpierrez, MD (Professor of Medicine, Emory University) — Principal investigator
First posted
Aug 9, 2013
Start date
Mar 2014
Primary completion
Aug 30, 2020
Completion
Aug 30, 2020
Results posted
Nov 3, 2021
Last update
Nov 3, 2021

Study contacts

Guillermo E Umpierrez, MD
principal investigator · Emory University SOM

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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