Trial Outcomes & Findings for 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 (NCT NCT02455076)

NCT ID: NCT02455076

Last Updated: 2019-06-20

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 150 participants
• Primary outcome timeframe: Duration of hospital stay, an expected average of 10 days.
• Results posted on: 2019-06-20

Participant Flow

Participants for outpatient part of the study were recruited from participants completed inpatient part of the study. 103 (out of 145 participants who complied inpatient trial) consented to be randomized into one of the two outpatient arms.

Participant milestones

Measure	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.	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.	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.	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.	Insulin Only Outpatient Patients are treated with insulin only
Inpatient STARTED	47	51	52	0	0
Inpatient COMPLETED	43	50	52	0	0
Inpatient NOT COMPLETED	4	1	0	0	0
Outpatient STARTED	0	0	0	48	55
Outpatient COMPLETED	0	0	0	42	43
Outpatient NOT COMPLETED	0	0	0	6	12

Reasons for withdrawal

Measure	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.	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.	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.	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.	Insulin Only Outpatient Patients are treated with insulin only
Inpatient Withdrawal by Subject	1	0	0	0	0
Inpatient Discharged <24 h after admission	0	1	0	0	0
Inpatient Adverse Event	3	0	0	0	0
Outpatient Adverse Event	0	0	0	5	0
Outpatient Lost to Follow-up	0	0	0	1	12

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Exenatide Inpatient n=47 Participants 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 Plus Glargine Insulin Inpatient n=51 Participants 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.	Basal Bolus Regimen Inpatient n=52 Participants 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.	Exenatide Outpatient n=48 Participants 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.	Insulin Only Outpatient n=55 Participants patients will be treated with Insulin only	Total n=253 Participants Total of all reporting groups
Age, Continuous Inpatient	55 years STANDARD_DEVIATION 12 • n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	55 years STANDARD_DEVIATION 12 • n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	57 years STANDARD_DEVIATION 11 • n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	—	—	56 years STANDARD_DEVIATION 12 • n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Age, Continuous Outpatient	—	—	—	52.7 years STANDARD_DEVIATION 12.9 • n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	54.8 years STANDARD_DEVIATION 10.0 • n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	53.1 years STANDARD_DEVIATION 11.1 • n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Sex: Female, Male Inpatient · Female	23 Participants n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	25 Participants n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	26 Participants n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	74 Participants n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Sex: Female, Male Inpatient · Male	24 Participants n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	26 Participants n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	26 Participants n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	76 Participants n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Sex: Female, Male Outpatient · Female	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	21 Participants n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	27 Participants n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	48 Participants n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Sex: Female, Male Outpatient · Male	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	27 Participants n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	28 Participants n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	55 Participants n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Inpatient · American Indian or Alaska Native	0 Participants n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Inpatient · Asian	0 Participants n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Inpatient · Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Inpatient · Black or African American	35 Participants n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	33 Participants n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	35 Participants n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	103 Participants n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Inpatient · White	10 Participants n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	15 Participants n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	16 Participants n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	41 Participants n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Inpatient · More than one race	0 Participants n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Inpatient · Unknown or Not Reported	2 Participants n=47 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	3 Participants n=51 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	1 Participants n=52 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	6 Participants n=150 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Outpatient · American Indian or Alaska Native	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Outpatient · Asian	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Outpatient · Native Hawaiian or Other Pacific Islander	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Outpatient · Black or African American	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	38 Participants n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	43 Participants n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	81 Participants n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Outpatient · White	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	8 Participants n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	12 Participants n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	20 Participants n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Outpatient · More than one race	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Race (NIH/OMB) Outpatient · Unknown or Not Reported	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	2 Participants n=48 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	0 Participants n=55 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient	2 Participants n=103 Participants • Number analyzed in row differs from overall as there are two study periods: inpatient and outpatient
Region of Enrollment United States · Inpatient	47 Participants n=47 Participants	51 Participants n=51 Participants	52 Participants n=52 Participants	0 Participants n=48 Participants	0 Participants n=55 Participants	150 Participants n=253 Participants
Region of Enrollment United States · Outpatient	0 Participants n=47 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	48 Participants n=48 Participants	55 Participants n=55 Participants	103 Participants n=253 Participants

PRIMARY outcome

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

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).

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Mean Daily Blood Glucose Concentration Inpatient	177.1 mg/dL Standard Deviation 41	154.1 mg/dL Standard Deviation 39	166.1 mg/dL Standard Deviation 40

PRIMARY outcome

Timeframe: 12 weeks from discharge.

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.

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Change in HbA1c Concentration Inpatient	-1.3 percentage of HbA1c Standard Deviation 1.5	-1.1 percentage of HbA1c Standard Deviation 2.2	-1.4 percentage of HbA1c Standard Deviation 1.1

SECONDARY outcome

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

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Mean Fasting Blood Glucose Levels Inpatient	177.1 mg/dL Standard Deviation 46.8	146.8 mg/dL Standard Deviation 39.7	157.7 mg/dL Standard Deviation 47.0

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Mean Premeal Blood Glucose Levels Inpatient	178.7 mg/dL Standard Deviation 42.8	153.4 mg/dL Standard Deviation 39.4	161.8 mg/dL Standard Deviation 42.1

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Incidence of Hypoglycemic Events Inpatient	0 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Incidence of Hyperglycemic Events Inpatient	10.4 percentage of readings Standard Deviation 24	5.1 percentage of readings Standard Deviation 16	11.2 percentage of readings Standard Deviation 23

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Total Daily Dose of Insulin Inpatient	8.1 units/day Standard Deviation 5	17.7 units/day Standard Deviation 11	28 units/day Standard Deviation 15

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Average Number of Days of Hospital Stay	4 days Interval 2.0 to 8.0	5 days Interval 3.0 to 7.0	4 days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Incidence of the Need for ICU Care Inpatient	2 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Hospital Mortality	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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.

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Hospital Complications	4 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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.

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Incidence of Acute Kidney Injury Inpatient	3 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Incidence of Gastrointestinal Adverse Events Inpatient	5 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 10 days

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Number of Patients With Severe Hypoglycemic Events Inpatient	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks after discharge

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

Outcome measures

Measure	Exenatide n=46 Participants 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 Plus Glargine Insulin n=50 Participants 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.	Basal Bolus Regimen n=52 Participants 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.
Incidence of Hospital Readmissions	4 Participants	16 Participants	6 Participants

SECONDARY outcome

Timeframe: 12 weeks after discharge

Fasting Blood Glucose Levels were measured using blood test

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Mean Fasting Blood Glucose Levels During Outpatient Period	146.5 mg/dL Standard Deviation 62.7	133.2 mg/dL Standard Deviation 26.1	—

SECONDARY outcome

Timeframe: 12 weeks after discharge

Mean Daily Blood Glucose Concentration will be calculated and recorded.

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Mean Daily Blood Glucose Concentration During Outpatient Period	155.1 mg/dL Standard Deviation 60.9	144.7 mg/dL Standard Deviation 31.6	—

SECONDARY outcome

Timeframe: 12 weeks after discharge

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
The Number of Patients With Hypoglycemia Outpatient	7 Participants	7 Participants	—

SECONDARY outcome

Timeframe: 12 weeks after discharge

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Number of Patients With Severe Hypoglycemic Events	1 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Time of discharge, 12 weeks after discharge

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Change in Body Weight	-2.3 pounds Standard Deviation 7.0	-1.2 pounds Standard Deviation 9.3	—

SECONDARY outcome

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

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Change in Body Mass Index	-0.8 kg/m2 Standard Deviation 2.6	-0.7 kg/m2 Standard Deviation 2.6	—

SECONDARY outcome

Timeframe: 12 weeks after discharge

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Number of Patients Who Had Emergency Room Visits	4 participants	12 participants	—

SECONDARY outcome

Timeframe: 12 weeks after discharge

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Number of Hospital Readmissions	12 number of readmissions	14 number of readmissions	—

SECONDARY outcome

Timeframe: 12 weeks from discharge.

Number of Acute Kidney Injury events will be recorded

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Number of Acute Kidney Injury Events	1 number of events	1 number of events	—

SECONDARY outcome

Timeframe: 12 weeks from discharge.

Number of Severe (require hospitalization) Gastrointestinal Adverse Events

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Number of Severe Gastrointestinal Adverse Events	1 number of events	1 number of events	—

SECONDARY outcome

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

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Change in Systolic Blood Pressure	3.2 mmHg Standard Deviation 24.3	1.8 mmHg Standard Deviation 16.4	—

SECONDARY outcome

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

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Change in Heart Rate	-3.1 heart beats/min Standard Deviation 9.8	0.2 heart beats/min Standard Deviation 12.9	—

SECONDARY outcome

Timeframe: 12 weeks from discharge.

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Efficacy, Measured by HbA1c Levels and no Weight Gain	8 Participants	5 Participants	—

SECONDARY outcome

Timeframe: 12 weeks from discharge.

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Efficacy, Measured by HbA1c Levels and no Hypoglycemia	11 Participants	8 Participants	—

SECONDARY outcome

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

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

Outcome measures

Measure	Exenatide n=42 Participants 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 Plus Glargine Insulin n=43 Participants 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.	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.
Change in Diastolic Blood Pressure	4.2 mmHg Standard Deviation 15.6	-1.0 mmHg Standard Deviation 11.7	—

Adverse Events

Exenatide Inpatient

Serious events: 7 serious events

Other events: 5 other events

Deaths: 0 deaths

Exenatide Plus Glargine Insulin Inpatient

Serious events: 12 serious events

Other events: 5 other events

Deaths: 0 deaths

Basal Bolus Regimen Inpatient

Serious events: 8 serious events

Other events: 1 other events

Deaths: 0 deaths

Exenatide Outpatient

Serious events: 11 serious events

Other events: 20 other events

Deaths: 1 deaths

Insulin Only Outpatient

Serious events: 11 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exenatide Inpatient n=47 participants at risk 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 Plus Glargine Insulin Inpatient n=51 participants at risk 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.	Basal Bolus Regimen Inpatient n=52 participants at risk 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.	Exenatide Outpatient n=48 participants at risk 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.	Insulin Only Outpatient n=55 participants at risk Patients with Type 2 Diabetes treated with Insulin only
General disorders Composite complications	6.4% 3/47 • Number of events 3 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	11.8% 6/51 • Number of events 6 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	7.7% 4/52 • Number of events 4 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	8.3% 4/48 • Number of events 4 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	3.6% 2/55 • Number of events 2 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Cardiac disorders Heart failure	0.00% 0/47 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/51 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	1.9% 1/52 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	4.2% 2/48 • Number of events 2 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	3.6% 2/55 • Number of events 2 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Renal and urinary disorders Acute renal failure	6.4% 3/47 • Number of events 3 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	11.8% 6/51 • Number of events 6 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	5.8% 3/52 • Number of events 3 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/48 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/55 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 1/47 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/51 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/52 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/48 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/55 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Vascular disorders Stroke	0.00% 0/47 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/51 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/52 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/48 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	1.8% 1/55 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Vascular disorders Acute Coronary syndrome	0.00% 0/47 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/51 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/52 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/48 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	1.8% 1/55 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Cardiac disorders Cardiac Arrhythmia	0.00% 0/47 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/51 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/52 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/48 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	1.8% 1/55 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Renal and urinary disorders Acute Kidney Injury	0.00% 0/47 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/51 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/52 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	2.1% 1/48 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	1.8% 1/55 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Surgical and medical procedures Surgery	0.00% 0/47 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/51 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/52 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	2.1% 1/48 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/55 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Infections and infestations Infection	0.00% 0/47 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/51 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/52 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	4.2% 2/48 • Number of events 2 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	3.6% 2/55 • Number of events 2 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Gastrointestinal disorders Gastro-intestinal event	0.00% 0/47 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/51 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/52 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	2.1% 1/48 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	1.8% 1/55 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)

Other adverse events

Measure	Exenatide Inpatient n=47 participants at risk 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 Plus Glargine Insulin Inpatient n=51 participants at risk 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.	Basal Bolus Regimen Inpatient n=52 participants at risk 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.	Exenatide Outpatient n=48 participants at risk 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.	Insulin Only Outpatient n=55 participants at risk Patients with Type 2 Diabetes treated with Insulin only
Gastrointestinal disorders Vomiting	2.1% 1/47 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	5.9% 3/51 • Number of events 3 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	0.00% 0/52 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	22.9% 11/48 • Number of events 11 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	1.8% 1/55 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Gastrointestinal disorders Nausea	10.6% 5/47 • Number of events 5 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	9.8% 5/51 • Number of events 5 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	1.9% 1/52 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	41.7% 20/48 • Number of events 20 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)	1.8% 1/55 • Number of events 1 • 14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)

Additional Information

Guillermo Umpierrez

Emory University

Phone: (404)778-1665

Email: geumpie@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place