GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01919489

CompletedPhase 4Results posted

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

Lead sponsor

Emory University

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

273

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7-10%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01919489

Org study IDIRB00068128

Secondary ID(UTN) U1111-1139-2991UNIVERSAL TRIAL NUMBER

Timeline

Milestones

Study first posted2013-08-09estimated

Primary completion2020-08-30actual

Study completion2020-08-30actual

Last update posted2021-11-03actual

Results first posted2021-11-03actual

Study start2014-03actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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

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).

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

Cardiovascular outcomes

Renal / kidney

Safety / tolerability / PK

Cardiovascular outcomes

2 endpoints

Secondary/registry result/low confidence

Emergency Room Visits and Readmissions

Time frame:After discharge, average 6 months

All-cause hospitalization

threshold achievement, event

componentsAll-cause hospitalization

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide + OADsNumber of participants with at least one ER visit	31	—
Number of participants with at least one hospital readmission	35	—
Glargine + OADsNumber of participants with at least one ER visit	23	—
Number of participants with at least one hospital readmission	43	—

Secondary/protocol endpoint/low confidence

Emergency Room Visits and Readmissions

Time frame:After discharge, average 6 months

threshold achievement, event

componentsAll-cause hospitalization

Weight & body composition

4 endpoints

Secondary/registry result

Change in Body Weight From Baseline

Time frame:After discharge, average 6 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kgs	95% CI
Liraglutide + OADsBaseline weight at discharge	101.0	—
Weight at six months	97.2	—
Weight change from baseline (discharge) to 6 months after discharge	-4.77	—
Glargine + OADsBaseline weight at discharge	98.2	—
Weight at six months	98.3	—
Weight change from baseline (discharge) to 6 months after discharge	0.6	—

Secondary/registry result

Change in BMI

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

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m2	95% CI
Liraglutide + OADsBaseline BMI	33.5	—
BMI at 26 weeks follow up	32.7	—
Glargine + OADsBaseline BMI	33.3	—
BMI at 26 weeks follow up	33.3	—

Secondary/protocol endpoint

Change in Body Weight From Baseline

Time frame:After discharge, average 6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

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

BMI, change

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Primary/registry result

Glycemic Control at Hospital Discharge and 6 Months Follow up

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), % (mmol/mol)	95% CI
Liraglutide + OADsHbA1C at hospital discharge	8.3	—
HbA1C at 6 months post-intervention	7.13	—
Glargine + OADsHbA1C at hospital discharge	8.4	—
HbA1C at 6 months post-intervention	7.68	—

Primary/protocol endpoint

Glycemic Control at Hospital Discharge and 6 Months Follow up

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

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)

descriptive, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide + OADsFasting blood glucose at 26 weeks follow up	7.61	—
Post-prandial blood glucose at 12 weeks	7.67	—
Postprandial blood glucose at 26 weeks follow up	8.23	—
Fasting blood glucose at 12 weeks	7.96	—
Glargine + OADsFasting blood glucose at 26 weeks follow up	8.56	—
Post-prandial blood glucose at 12 weeks	9.32	—
Postprandial blood glucose at 26 weeks follow up	8.72	—
Fasting blood glucose at 12 weeks	7.70	—

Secondary/registry result

HbA1c <7.0% and no Hypoglycemia

Time frame:After discharge, average 6 months

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide + OADs	34	—
Glargine + OADs	29	—

Secondary/registry result

HbA1c <7.0% and no Weight Gain

Time frame:After discharge, average 6 months

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide + OADs	32	—
Glargine + OADs	21	—

Secondary/registry result

HbA1c <7.0% and no Hypoglycemia

Time frame:After discharge, average 12 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide + OADs	40	—
Glargine + OADs	31	—

Secondary/registry result

Total Daily Dose of Insulin

Time frame:After discharge, average 6 months

descriptive

Posted result

Group	Value (mean), IU per day	95% CI
Liraglutide + OADs	0	—
Glargine + OADs	20.9	—

Secondary/registry result/low confidence

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

Time frame:26 weeks post-intervention

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide + OADs	34	—
Glargine + OADs	34	—

Secondary/protocol endpoint

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)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

HbA1c <7.0% and no Hypoglycemia

Time frame:After discharge, average 6 months

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c <7.0% and no Weight Gain

Time frame:After discharge, average 6 months

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

HbA1c <7.0% and no Hypoglycemia

Time frame:After discharge, average 12 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Total Daily Dose of Insulin

Time frame:After discharge, average 6 months

descriptive, improvement

Secondary/protocol endpoint

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

Time frame:26 weeks post-intervention

descriptive

Renal / kidney

2 endpoints

Secondary/registry result

Acute Renal Failure

Time frame:After discharge, average 6 months

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide + OADs	1	—
Glargine + OADs	3	—

Secondary/protocol endpoint

Acute Renal Failure

Time frame:After discharge, average 6 months

categorical status, event

Cardiometabolic biomarkers

6 endpoints

Secondary/registry result

Change in Cardiovascular Risk Factors: Blood Pressure

Time frame:Baseline, 26 weeks post-intervention

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide + OADsSystolic blood pressure at baseline	134	—
Systolic blood pressure at 26 weeks follow up	136	—
Diastolic blood pressure at baseline	79	—
Diastolic blood pressure at 26 weeks follow up	80	—
Glargine + OADsSystolic blood pressure at baseline	130	—
Systolic blood pressure at 26 weeks follow up	135	—
Diastolic blood pressure at baseline	77	—
Diastolic blood pressure at 26 weeks follow up	79	—

Secondary/registry result

Cardiovascular Risk Factor: Heart Rate

Time frame:26 weeks post-intervention

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats/min	95% CI
Liraglutide + OADsHeart rate at baseline (discharge)	79	—
Heart rate at 6 months post-discharge	83	—
Glargine + OADsHeart rate at baseline (discharge)	79	—
Heart rate at 6 months post-discharge	79	—

Secondary/registry result

Cardiovascular Risk Factor: Lipid Profile

Time frame:26 weeks post-intervention

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide + OADs	190	—
Glargine + OADs	130	—

Secondary/protocol endpoint

Change in Cardiovascular Risk Factors: Blood Pressure

Time frame:Baseline, 26 weeks post-intervention

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Cardiovascular Risk Factor: Heart Rate

Time frame:26 weeks post-intervention

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Cardiovascular Risk Factor: Lipid Profile

Time frame:26 weeks post-intervention

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Hypoglycemic Episodes

Time frame:After discharge, average 6 months

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide + OADsParticipants who had at least one hypoglycemic events (<70 mg/dl)	18	—
Participants who had at least one severe hypoglycemic event (<40 mg/dl)	2	—
Glargine + OADsParticipants who had at least one hypoglycemic events (<70 mg/dl)	31	—
Participants who had at least one severe hypoglycemic event (<40 mg/dl)	3	—

Secondary/protocol endpoint

Hypoglycemic Episodes

Time frame:After discharge, average 6 months

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.