Exenatide Inpatient Trial: A Randomized Controlled Pilot... | NCT02455076

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exenatide inpatient	Active Comparator	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive exenatide (Byetta®) twice daily. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale.	Drug: Exenatide
Exenatide plus glargine insulin inpatient	Active Comparator	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive exenatide twice daily and glargine once daily. Glargine insulin will be given once daily at the same time. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale.	Drug: Exenatide Drug: Glargine
Basal bolus regimen inpatient	Active Comparator	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale.	Drug: Glargine Drug: Rapid-acting insulin analogs
Exenatide outpatient	Active Comparator	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive exenatide (Byetta®) twice daily. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exenatide	Drug	Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Daily Blood Glucose Concentration Inpatient	The levels of blood glucose (BG) will be measured before each meal and at bedtime using a glucose meter. Blood glucose will be measured at baseline and during the hospital stay (up to 10 days).	Duration of hospital stay, an expected average of 10 days.
Change in HbA1c Concentration Inpatient	The difference in the levels of HbA1c at discharge and at 12 weeks from discharge will be measured. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.	12 weeks from discharge.

Secondary Outcomes

Measure	Description	Time Frame
Mean Fasting Blood Glucose Levels Inpatient	The blood glucose levels prior to the patient's first meal of the day will be assessed using a glucose meter.	Duration of hospital stay, an expected average of 10 days.
Mean Premeal Blood Glucose Levels Inpatient

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
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).
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).
Admission HbA1c between 7% and 10%
BMI range: > 25 Kg/m^2 and < 45 Kg/m^2

Exclusion Criteria:

Age < 18 or > 80 years
Subjects with increased blood glucose (BG) concentration, but without a history of diabetes (stress hyperglycemia)
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).
Treatment with high-dose (>0.5 unit/kg/day) insulin or with GLP-1 RA during the past 3 months prior to admission.
Patients that required ICU care during the hospital admission.
Recurrent severe hypoglycemia or hypoglycemic unawareness.
Subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or those expected to require gastrointestinal suction.
Patients with clinically relevant pancreatic or gallbladder disease.
Patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease),
History of hypersensitivity to exenatide
Treatment with oral or injectable corticosteroid (equal to a prednisone dose >5 mg/day), parenteral nutrition and immunosuppressive treatment.
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.
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Female subjects who are pregnant or breast feeding at time of enrollment into the study.

Name	Affiliation	Role
Guillermo E Umpierrez, MD, CDE	Emory University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Grady Memorial Hospital		Atlanta	Georgia	30303	United States
Emory University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30679302	Derived	Fayfman M, Galindo RJ, Rubin DJ, Mize DL, Anzola I, Urrutia MA, Ramos C, Pasquel FJ, Haw JS, Vellanki P, Wang H, Albury BS, Weaver R, Cardona S, Umpierrez GE. 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 Care. 2019 Mar;42(3):450-456. doi: 10.2337/dc18-1760. Epub 2019 Jan 24.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Exenatide Inpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
FG001	Exenatide Plus Glargine Insulin Inpatient

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 4, 2017

Arm/Group Information

ID	Title	Description
BG000	Exenatide Inpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
BG001	Exenatide Plus Glargine Insulin Inpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
BG002	Basal Bolus Regimen Inpatient	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.
BG003	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
BG004	Insulin Only Outpatient	patients will be treated with Insulin only
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient

Mean

Standard Deviation

years

Title	Denominators	Categories
Inpatient	ParticipantsBG00047 ParticipantsBG00151 ParticipantsBG00252 ParticipantsBG003

Sex: Female, Male

Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient

Count of Participants

Participants

Title	Denominators	Categories
Inpatient	ParticipantsBG00047 ParticipantsBG00151 ParticipantsBG002

Race (NIH/OMB)

Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient

Count of Participants

Participants

Title	Denominators	Categories
Inpatient	ParticipantsBG00047 ParticipantsBG00151 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
United States	ParticipantsBG00047 ParticipantsBG00151 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Daily Blood Glucose Concentration Inpatient

The levels of blood glucose (BG) will be measured before each meal and at bedtime using a glucose meter. Blood glucose will be measured at baseline and during the hospital stay (up to 10 days).

Posted

Mean

Standard Deviation

mg/dL

Duration of hospital stay, an expected average of 10 days.

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Units	Counts
Participants	OG00046 OG00150 OG00252

Title

Denominators

Categories

Title	Measurements
	OG000177.1± 41 OG001154.1± 39 OG002166.1± 40

Primary

Change in HbA1c Concentration Inpatient

The difference in the levels of HbA1c at discharge and at 12 weeks from discharge will be measured. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.

Posted

Mean

Standard Deviation

percentage of HbA1c

12 weeks from discharge.

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen

Secondary

Mean Fasting Blood Glucose Levels Inpatient

The blood glucose levels prior to the patient's first meal of the day will be assessed using a glucose meter.

Posted

Mean

Standard Deviation

mg/dL

Duration of hospital stay, an expected average of 10 days.

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Mean Premeal Blood Glucose Levels Inpatient

The blood glucose levels prior to each meal will using a glucose meter.

Posted

Mean

Standard Deviation

mg/dL

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Incidence of Hypoglycemic Events Inpatient

The number of patients with hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.

Posted

Count of Participants

Participants

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Incidence of Hyperglycemic Events Inpatient

Percent of readings with hyperglycemia (blood glucose levels > 240 mg/dL)

Posted

Mean

Standard Deviation

percentage of readings

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Total Daily Dose of Insulin Inpatient

The total daily dose of insulin needed for glycemic control from baseline through the patient's hospital stay will be recorded.

Posted

Mean

Standard Deviation

units/day

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Average Number of Days of Hospital Stay

The average number of days in the hospital for subjects will be calculated.

Posted

Median

Inter-Quartile Range

days

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Incidence of the Need for ICU Care Inpatient

The total number of patients who require transfer to the ICU will be recorded.

Posted

Count of Participants

Participants

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Hospital Mortality

The total number of subject deaths during hospital stay will be recorded.

Posted

Count of Participants

Participants

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Hospital Complications

The total number of subjects who experience hospital complications like nosocomial pneumonia, bacteremia, respiratory failure, acute renal failure, and wound infections (surgery patients) will be recorded. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.

Posted

Count of Participants

Participants

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen

Secondary

Incidence of Acute Kidney Injury Inpatient

The number of patients who experience acute kidney injury diagnosed by an increment in serum creatinine >0.5 mg/dL from admission value or 50% of baseline value will be recorded.

Posted

Count of Participants

Participants

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Incidence of Gastrointestinal Adverse Events Inpatient

The number of subjects who experience gastrointestinal side effects including nausea, vomiting and diarrhea will be recorded.

Posted

Count of Participants

Participants

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Number of Patients With Severe Hypoglycemic Events Inpatient

Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be recorded.

Posted

Count of Participants

Participants

Duration of hospital stay, an expected average of 10 days

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Incidence of Hospital Readmissions

The number of patients who require readmission to the hospital from the time of discharge to 12 weeks after discharge will be recorded.

Posted

Count of Participants

Participants

12 weeks after discharge

ID	Title	Description
OG000	Exenatide	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Exenatide Plus Glargine Insulin	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.
OG002	Basal Bolus Regimen	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.

Secondary

Mean Fasting Blood Glucose Levels During Outpatient Period

Fasting Blood Glucose Levels were measured using blood test

Posted

Mean

Standard Deviation

mg/dL

12 weeks after discharge

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Mean Daily Blood Glucose Concentration During Outpatient Period

Mean Daily Blood Glucose Concentration will be calculated and recorded.

Posted

Mean

Standard Deviation

mg/dL

12 weeks after discharge

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

The Number of Patients With Hypoglycemia Outpatient

Occurrence of hypoglycemia (blood glucose levels < 70 mg) will be identified by blood test

Posted

Count of Participants

Participants

12 weeks after discharge

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Number of Patients With Severe Hypoglycemic Events

Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be detected by blood test

Posted

Count of Participants

Participants

12 weeks after discharge

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Change in Body Weight

The change in Body Weight from discharge to 12 weeks after discharge will be recorded

Posted

Mean

Standard Deviation

pounds

Time of discharge, 12 weeks after discharge

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Change in Body Mass Index

The change in BMI from discharge to 12 weeks after discharge will be calculated

Posted

Mean

Standard Deviation

kg/m2

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

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Number of Patients Who Had Emergency Room Visits

The number of patients who had emergency room visits from the time of discharge to 12 weeks after discharge will be recorded.

Posted

Number

participants

12 weeks after discharge

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Number of Hospital Readmissions

Number of hospital readmissions during 12 weeks after discharge will be recorded

Posted

Number

number of readmissions

12 weeks after discharge

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Number of Acute Kidney Injury Events

Number of Acute Kidney Injury events will be recorded

Posted

Number

number of events

12 weeks from discharge.

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Number of Severe Gastrointestinal Adverse Events

Number of Severe (require hospitalization) Gastrointestinal Adverse Events

Posted

Number

number of events

12 weeks from discharge.

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Change in Systolic Blood Pressure

Change in Systolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded

Posted

Mean

Standard Deviation

mmHg

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

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Change in Heart Rate

Change in heart rate from the time of discharge to 12 weeks after discharge will be recorded

Posted

Mean

Standard Deviation

heart beats/min

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

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Efficacy, Measured by HbA1c Levels and no Weight Gain

Number of patients who have an HbA1c <7.0% and no weight gain at 12 weeks from discharge will be recorded.

Posted

Count of Participants

Participants

12 weeks from discharge.

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Efficacy, Measured by HbA1c Levels and no Hypoglycemia

Number of patients who have an HbA1c <7.0% and no hypoglycemia at 12 weeks from discharge will be recorded.

Posted

Count of Participants

Participants

12 weeks from discharge.

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Secondary

Change in Diastolic Blood Pressure

Change in Diastolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded

Posted

Mean

Standard Deviation

mmHg

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

ID	Title	Description
OG000	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.
OG001	Insulin Only Outpatient	Patients are treated with insulin only

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Exenatide Inpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.	0	47	7	47	5	47
EG001	Exenatide Plus Glargine Insulin Inpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response. Glargine: Glargine will be given once daily, at the same time of day.	0	51	12	51	5	51
EG002	Basal Bolus Regimen Inpatient	Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs.	0	52	8	52	1	52
EG003	Exenatide Outpatient	Exenatide: Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm.	1	48	11	48	20	48
EG004	Insulin Only Outpatient	Patients with Type 2 Diabetes treated with Insulin only	0	55	11	55	1	55

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Composite complications	General disorders	Non-systematic Assessment	EG0003 events3 affected47 at risk EG0016 events6 affected51 at risk EG0024 events4 affected52 at risk EG0034 events4 affected48 at risk EG0042 events2 affected55 at risk
Heart failure	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected51 at risk EG0021 events1 affected52 at risk EG003
Acute renal failure	Renal and urinary disorders	Non-systematic Assessment	EG0003 events3 affected47 at risk EG0016 events6 affected51 at risk EG0023 events3 affected52 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected51 at risk EG0020 events0 affected52 at risk EG003
Stroke	Vascular disorders	Non-systematic Assessment	EG0000 affected47 at risk EG0010 affected51 at risk EG0020 affected52 at risk EG003
Acute Coronary syndrome	Vascular disorders	Non-systematic Assessment	EG0000 affected47 at risk EG0010 affected51 at risk EG0020 affected52 at risk EG003
Cardiac Arrhythmia	Cardiac disorders	Non-systematic Assessment	EG0000 affected47 at risk EG0010 affected51 at risk EG0020 affected52 at risk EG003
Acute Kidney Injury	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected47 at risk EG0010 affected51 at risk EG0020 affected52 at risk EG003
Surgery	Surgical and medical procedures	Non-systematic Assessment	EG0000 affected47 at risk EG0010 affected51 at risk EG0020 affected52 at risk EG003
Infection	Infections and infestations	Non-systematic Assessment	EG0000 affected47 at risk EG0010 affected51 at risk EG0020 affected52 at risk EG003
Gastro-intestinal event	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected47 at risk EG0010 affected51 at risk EG0020 affected52 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological
D001685	Biological Factors
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Vomiting	Gastrointestinal disorders		Non-systematic Assessment		EG0001 events1 affected47 at risk EG0013 events3 affected51 at risk EG0020 events0 affected52 at risk EG00311 events11 affected48 at risk EG0041 events1 affected55 at risk
Nausea	Gastrointestinal disorders		Non-systematic Assessment		EG0005 events5 affected47 at risk EG0015 events5 affected51 at risk EG0021 events1 affected52 at risk EG003