GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes

Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes

Lead sponsor

Emory University

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

150

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7-10%

Primary endpoints

•Mean Daily Blood Glucose Concentration Inpatient•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 IDNCT02455076

Org study IDIRB00080596

Timeline

Milestones

Study first posted2015-05-27estimated

Last update posted2019-06-20actual

Results first posted2019-06-20actual

Study start2015-09actual (month precision)

Primary completion2018-03actual (month precision)

Study completion2018-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. A known history of Type 2 Diabetes receiving either diet alone or oral antidiabetic drugs (OAD) including insulin secretagogues, pioglitazone, DPP4 inhibitors, or metformin as monotherapy or in combination therapy, or low-dose insulin at <0.5 unit/kg/day.

2. Males or females between the ages of 18 and 80 years discharged after hospital admission from general medicine and surgery services (non-Intensive Care Unit setting).

3. Subjects with an admission / randomization BG < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).

4. Admission HbA1c between 7% and 10%

5. BMI range: > 25 Kg/m^2 and < 45 Kg/m^2

Exclusion criteria

1. Age < 18 or > 80 years

2. Subjects with increased blood glucose (BG) concentration, but without a history of diabetes (stress hyperglycemia)

3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 Kg/m^2 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria).

4. Treatment with high-dose (>0.5 unit/kg/day) insulin or with GLP-1 RA during the past 3 months prior to admission.

5. Patients that required ICU care during the hospital admission.

6. Recurrent severe hypoglycemia or hypoglycemic unawareness.

7. Subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or those expected to require gastrointestinal suction.

8. Patients with clinically relevant pancreatic or gallbladder disease.

9. Patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance < 30 ml/min)

10. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease),

11. History of hypersensitivity to exenatide

12. Treatment with oral or injectable corticosteroid (equal to a prednisone dose >5 mg/day), parenteral nutrition and immunosuppressive treatment.

13. Patients with history of heavy alcohol use (female > 2 drinks per day, male > 3 drinks per day) or drug abuse within 3 months prior to admission.

14. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

15. Female subjects who are pregnant or breast feeding at time of enrollment into the study.

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

Safety / tolerability / PK

Cardiovascular outcomes

Cardiometabolic biomarkers

Weight & body composition

Renal / kidney

Cardiovascular outcomes

4 endpoints

Secondary/protocol endpoint/low confidence

Average Number of Days of Hospital Stay

Time frame:Duration of hospital stay, an expected average of 10 days

descriptive

Posted result

Group	Value (median), days	95% CI
Exenatide	4	2 – 8
Exenatide Plus Glargine Insulin	5	3 – 7
Basal Bolus Regimen	4	2 – 5

Secondary/protocol endpoint

Incidence of Hospital Readmissions

Time frame:12 weeks after discharge

All-cause hospitalization

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide	4	—
Exenatide Plus Glargine Insulin	16	—
Basal Bolus Regimen	6	—

Secondary/protocol endpoint/low confidence

Number of Patients Who Had Emergency Room Visits

Time frame:12 weeks after discharge

event count, event

Posted result

Group	Value (number), participants	95% CI
Exenatide Outpatient	4	—
Insulin Only Outpatient	12	—

Secondary/protocol endpoint

Number of Hospital Readmissions

Time frame:12 weeks after discharge

All-cause hospitalization

event count, event

Posted result

Group	Value (number), number of readmissions	95% CI
Exenatide Outpatient	12	—
Insulin Only Outpatient	14	—

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight

Time frame:Time of discharge, 12 weeks after discharge

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), pounds	95% CI
Exenatide Outpatient	-2.3	—
Insulin Only Outpatient	-1.2	—

Secondary/protocol endpoint

Change in Body Mass Index

Time frame:Discharge (after day 10 or hospital stay), 12 weeks after discharge 12 weeks after discharge

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m2	95% CI
Exenatide Outpatient	-0.8	—
Insulin Only Outpatient	-0.7	—

Glycemic / diabetes

10 endpoints

Primary/protocol endpoint

Mean Daily Blood Glucose Concentration Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days.

descriptive, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide	177.1	—
Exenatide Plus Glargine Insulin	154.1	—
Basal Bolus Regimen	166.1	—

Primary/protocol endpoint

Change in HbA1c Concentration Inpatient

Time frame:12 weeks from discharge.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of HbA1c	95% CI
Exenatide	-1.3	—
Exenatide Plus Glargine Insulin	-1.1	—
Basal Bolus Regimen	-1.4	—

Secondary/protocol endpoint

Mean Fasting Blood Glucose Levels Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days.

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide	177.1	—
Exenatide Plus Glargine Insulin	146.8	—
Basal Bolus Regimen	157.7	—

Secondary/protocol endpoint

Mean Premeal Blood Glucose Levels Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days

descriptive

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide	178.7	—
Exenatide Plus Glargine Insulin	153.4	—
Basal Bolus Regimen	161.8	—

Secondary/protocol endpoint

Incidence of Hyperglycemic Events Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days

threshold achievement, improvement

Posted result

Group	Value (mean), percentage of readings	95% CI
Exenatide	10.4	—
Exenatide Plus Glargine Insulin	5.1	—
Basal Bolus Regimen	11.2	—

Secondary/protocol endpoint/low confidence

Total Daily Dose of Insulin Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days

descriptive

Posted result

Group	Value (mean), units/day	95% CI
Exenatide	8.1	—
Exenatide Plus Glargine Insulin	17.7	—
Basal Bolus Regimen	28	—

Secondary/protocol endpoint

Mean Fasting Blood Glucose Levels During Outpatient Period

Time frame:12 weeks after discharge

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide Outpatient	146.5	—
Insulin Only Outpatient	133.2	—

Secondary/protocol endpoint

Mean Daily Blood Glucose Concentration During Outpatient Period

Time frame:12 weeks after discharge

descriptive, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide Outpatient	155.1	—
Insulin Only Outpatient	144.7	—

Secondary/protocol endpoint

Efficacy, Measured by HbA1c Levels and no Weight Gain

Time frame:12 weeks from discharge.

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide Outpatient	8	—
Insulin Only Outpatient	5	—

Secondary/protocol endpoint

Efficacy, Measured by HbA1c Levels and no Hypoglycemia

Time frame:12 weeks from discharge.

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide Outpatient	11	—
Insulin Only Outpatient	8	—

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Number of Acute Kidney Injury Events

Time frame:12 weeks from discharge.

event count, event

Posted result

Group	Value (number), number of events	95% CI
Exenatide Outpatient	1	—
Insulin Only Outpatient	1	—

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:Discharge (after day 10 or hospital stay), 12 weeks after discharge

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide Outpatient	3.2	—
Insulin Only Outpatient	1.8	—

Secondary/protocol endpoint

Change in Heart Rate

Time frame:Discharge (after day 10 or hospital stay), 12 weeks after discharge

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), heart beats/min	95% CI
Exenatide Outpatient	-3.1	—
Insulin Only Outpatient	0.2	—

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:Discharge (after day 10 or hospital stay), 12 weeks after discharge

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide Outpatient	4.2	—
Insulin Only Outpatient	-1.0	—

Safety / tolerability / PK

10 endpoints

Secondary/protocol endpoint

Incidence of Hypoglycemic Events Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days

Documented hypoglycemia

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide	0	—
Exenatide Plus Glargine Insulin	3	—
Basal Bolus Regimen	6	—

Secondary/protocol endpoint

Incidence of the Need for ICU Care Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide	2	—
Exenatide Plus Glargine Insulin	3	—
Basal Bolus Regimen	0	—

Secondary/protocol endpoint

Hospital Mortality

Time frame:Duration of hospital stay, an expected average of 10 days

Death (safety endpoint)

event count, event

SNOMED 419620001

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide	0	—
Exenatide Plus Glargine Insulin	0	—
Basal Bolus Regimen	0	—

Secondary/protocol endpoint

Hospital Complications

Time frame:Duration of hospital stay, an expected average of 10 days

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide	4	—
Exenatide Plus Glargine Insulin	6	—
Basal Bolus Regimen	3	—

Secondary/protocol endpoint

Incidence of Acute Kidney Injury Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days

threshold achievement, event

LOINC 2160-0

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide	3	—
Exenatide Plus Glargine Insulin	6	—
Basal Bolus Regimen	3	—

Secondary/protocol endpoint

Incidence of Gastrointestinal Adverse Events Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days

Nausea

event count, event

componentsNausea, Vomiting, Diarrhea

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide	5	—
Exenatide Plus Glargine Insulin	5	—
Basal Bolus Regimen	1	—

Secondary/protocol endpoint

Number of Patients With Severe Hypoglycemic Events Inpatient

Time frame:Duration of hospital stay, an expected average of 10 days

Severe hypoglycemia

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide	0	—
Exenatide Plus Glargine Insulin	0	—
Basal Bolus Regimen	0	—

Secondary/protocol endpoint

The Number of Patients With Hypoglycemia Outpatient

Time frame:12 weeks after discharge

Documented hypoglycemia

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide Outpatient	7	—
Insulin Only Outpatient	7	—

Secondary/protocol endpoint

Number of Patients With Severe Hypoglycemic Events

Time frame:12 weeks after discharge

Severe hypoglycemia

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide Outpatient	1	—
Insulin Only Outpatient	4	—

Secondary/protocol endpoint

Number of Severe Gastrointestinal Adverse Events

Time frame:12 weeks from discharge.

event count, event

Posted result

Group	Value (number), number of events	95% CI
Exenatide Outpatient	1	—
Insulin Only Outpatient	1	—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

A Randomized Controlled Trial on the Safety and Efficacy of Exenatide Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes.
Diabetes care2019 Mar (month)PMID30679302doi:10.2337/dc18-1760via clinicaltrials gov reference derived + pubmed nct search

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.