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

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02455076
• Collaborator: (none)
• Enrollment: 150
• Locations: 2
• Arms: 5
• Actual Duration (Months): 30
• Patients Per Site: 75
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of this study is to try and achieve similar glycemic control in general non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes with exenatide alone or in combination with basal insulin as compared to treatment with basal bolus insulin alone. The association between hyperglycemia and poor clinical outcomes in patients with diabetes is well established. Previous studies have shown that basal bolus insulin regimens improve glycemic control and reduce the rate of hospital complications compared to sliding scale regular insulin (SSRI) therapy, but has a significant risk of hypoglycemia. The investigators will compare the efficacy and safety of exenatide alone or in combination with basal insulin to control high blood glucose levels resulting in a lower risk of hypoglycemia.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Exenatide; Drug: Glargine; Drug: Rapid-acting insulin analogs	Phase 4

Detailed Description

The association between hyperglycemia and poor clinical outcomes in patients with diabetes is well established. Data from previous trials in hospitalized patients have shown a strong association between hyperglycemia and poor clinical outcomes, such as mortality, morbidity, length of stay (LOS), infections and overall complications. Basal bolus insulin regimens improve glycemic control and reduce the rate of hospital complications compared to sliding scale regular insulin (SSRI). However, the use of basal bolus is labor intensive, requiring multiple daily insulin injections, and has a significant risk of hypoglycemia. The investigators will study if treatment with exenatide alone or in combination with basal insulin will result in similar glycemic control and a lower frequency of hypoglycemia than treatment with basal bolus in general non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Exenatide inpatient 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 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.; Other Names: Byetta
Active Comparator: Exenatide plus glargine insulin inpatient 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; 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.; Other Names: Byetta ; Drug: Glargine; Glargine will be given once daily, at the same time of day. If the BG is between 140-200 mg/dL, the dose will be 0.2 units/kg/day; for BG levels 201-400 mg/dL, the dose will be 0.25 units/kg/day. The patients will be discharged on glargine once daily at 50% of the hospital dose.The total daily dose (TDD) of glargine is based on the patient's fasting BG levels for the last 2 days. FBG >180 mg/dL, no hypoglycemia; glargine increased by 4 IU. FBG >140 mg/dL, no hypoglycemia; glargine increased by 2 IU. FBG 100-140 mg/dL, no hypoglycemia; no change in dosage. FBG 70 - 99 mg/dl, decrease glargine by 4 IU or 10% of TDD. FBG or RBG < 70 mg/dl, decrease glargine by 8 IU or 20% of TDD. FBG or RBG < 40 mg/dl, decrease dose of glargine by 30%.; Other Names: Lantus
Active Comparator: 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. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale.	Drug: Glargine; Glargine will be given once daily, at the same time of day. If the BG is between 140-200 mg/dL, the dose will be 0.2 units/kg/day; for BG levels 201-400 mg/dL, the dose will be 0.25 units/kg/day. The patients will be discharged on glargine once daily at 50% of the hospital dose.The total daily dose (TDD) of glargine is based on the patient's fasting BG levels for the last 2 days. FBG >180 mg/dL, no hypoglycemia; glargine increased by 4 IU. FBG >140 mg/dL, no hypoglycemia; glargine increased by 2 IU. FBG 100-140 mg/dL, no hypoglycemia; no change in dosage. FBG 70 - 99 mg/dl, decrease glargine by 4 IU or 10% of TDD. FBG or RBG < 70 mg/dl, decrease glargine by 8 IU or 20% of TDD. FBG or RBG < 40 mg/dl, decrease dose of glargine by 30%.; Other Names: Lantus ; Drug: Rapid-acting insulin analogs; If the BG levels are >140 mg/dL, rapid acting insulin analogs will be administered following the "supplemental/sliding scale" protocol. If a patient is able and expected to eat all or most of his/her meals, supplemental insulin will be administered before each meal and at bedtime following the "usual" dose of the sliding scale protocol. If a patient is not able to eat, supplemental insulin will be administered every 6 hours following the "sensitive" dose of the sliding scale. If the BG is 141-180 mg/dL, then 2,3 or 4 units of insulin will be given; for BG 181 - 220 mg/dL; the units of insulin will be 3, 4 or 6; for BG 221 - 260 mg/dL, the units of insulin will be 4,5 or 8; for BG 261 - 300 mg/dL, the units of insulin will be 5, 6 or 10; for BG 301 - 350, the insulin will be 6, 8 or 12 units; for BG 351 - 400 mg/dL, the units of insulin will be 7,10 or 14; for BG> 400 mg/dL, the insulin will be 8,12 or 16 units.
Active Comparator: Exenatide outpatient 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 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.; Other Names: Byetta
Active Comparator: Insulin Only Patients with Type 2 Diabetes will be treated with Insulin only	Drug: Glargine; Glargine will be given once daily, at the same time of day. If the BG is between 140-200 mg/dL, the dose will be 0.2 units/kg/day; for BG levels 201-400 mg/dL, the dose will be 0.25 units/kg/day. The patients will be discharged on glargine once daily at 50% of the hospital dose.The total daily dose (TDD) of glargine is based on the patient's fasting BG levels for the last 2 days. FBG >180 mg/dL, no hypoglycemia; glargine increased by 4 IU. FBG >140 mg/dL, no hypoglycemia; glargine increased by 2 IU. FBG 100-140 mg/dL, no hypoglycemia; no change in dosage. FBG 70 - 99 mg/dl, decrease glargine by 4 IU or 10% of TDD. FBG or RBG < 70 mg/dl, decrease glargine by 8 IU or 20% of TDD. FBG or RBG < 40 mg/dl, decrease dose of glargine by 30%.; Other Names: Lantus ; Drug: Rapid-acting insulin analogs; If the BG levels are >140 mg/dL, rapid acting insulin analogs will be administered following the "supplemental/sliding scale" protocol. If a patient is able and expected to eat all or most of his/her meals, supplemental insulin will be administered before each meal and at bedtime following the "usual" dose of the sliding scale protocol. If a patient is not able to eat, supplemental insulin will be administered every 6 hours following the "sensitive" dose of the sliding scale. If the BG is 141-180 mg/dL, then 2,3 or 4 units of insulin will be given; for BG 181 - 220 mg/dL; the units of insulin will be 3, 4 or 6; for BG 221 - 260 mg/dL, the units of insulin will be 4,5 or 8; for BG 261 - 300 mg/dL, the units of insulin will be 5, 6 or 10; for BG 301 - 350, the insulin will be 6, 8 or 12 units; for BG 351 - 400 mg/dL, the units of insulin will be 7,10 or 14; for BG> 400 mg/dL, the insulin will be 8,12 or 16 units.

Outcome Measures

Primary Outcome Measures

1. Mean Daily Blood Glucose Concentration Inpatient [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).

2. Change in HbA1c Concentration Inpatient [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.

Secondary Outcome Measures

1. Mean Fasting Blood Glucose Levels Inpatient [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.

2. Mean Premeal Blood Glucose Levels Inpatient [Duration of hospital stay, an expected average of 10 days]

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

3. Incidence of Hypoglycemic Events Inpatient [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.

4. Incidence of Hyperglycemic Events Inpatient [Duration of hospital stay, an expected average of 10 days]

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

5. Total Daily Dose of Insulin Inpatient [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.

6. Average Number of Days of Hospital Stay [Duration of hospital stay, an expected average of 10 days]

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

7. Incidence of the Need for ICU Care Inpatient [Duration of hospital stay, an expected average of 10 days]

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

8. Hospital Mortality [Duration of hospital stay, an expected average of 10 days]

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

9. Hospital Complications [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.

10. Incidence of Acute Kidney Injury Inpatient [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.

11. Incidence of Gastrointestinal Adverse Events Inpatient [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.

12. Number of Patients With Severe Hypoglycemic Events Inpatient [Duration of hospital stay, an expected average of 10 days]

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

13. Incidence of Hospital Readmissions [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.

14. Mean Fasting Blood Glucose Levels During Outpatient Period [12 weeks after discharge]

    Fasting Blood Glucose Levels were measured using blood test

15. Mean Daily Blood Glucose Concentration During Outpatient Period [12 weeks after discharge]

    Mean Daily Blood Glucose Concentration will be calculated and recorded.

16. The Number of Patients With Hypoglycemia Outpatient [12 weeks after discharge]

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

17. Number of Patients With Severe Hypoglycemic Events [12 weeks after discharge]

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

18. Change in Body Weight [Time of discharge, 12 weeks after discharge]

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

19. Change in Body Mass Index [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

20. Number of Patients Who Had Emergency Room Visits [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.

21. Number of Hospital Readmissions [12 weeks after discharge]

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

22. Number of Acute Kidney Injury Events [12 weeks from discharge.]

    Number of Acute Kidney Injury events will be recorded

23. Number of Severe Gastrointestinal Adverse Events [12 weeks from discharge.]

    Number of Severe (require hospitalization) Gastrointestinal Adverse Events

24. Change in Systolic Blood Pressure [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

25. Change in Heart Rate [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

26. Efficacy, Measured by HbA1c Levels and no Weight Gain [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.

27. Efficacy, Measured by HbA1c Levels and no Hypoglycemia [12 weeks from discharge.]

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

28. Change in Diastolic Blood Pressure [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

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

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

4. Admission HbA1c between 7% and 10%

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

Exclusion Criteria:

1. Age < 18 or > 80 years

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

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

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

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

6. Recurrent severe hypoglycemia or hypoglycemic unawareness.

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

8. Patients with clinically relevant pancreatic or gallbladder disease.

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

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

11. History of hypersensitivity to exenatide

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

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

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Memorial Hospital	Atlanta	Georgia	United States	30303
2	Emory University Hospital	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Guillermo E Umpierrez, MD, CDE, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 4, 2017

More Information

Publications

None provided.

• Responsible Party: Guillermo Umpierrez, MD, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02455076
• Other Study ID Numbers: IRB00080596
• First Posted: May 27, 2015
• Last Update Posted: Jun 20, 2019
• Last Verified: May 1, 2019

• Keywords provided by Guillermo Umpierrez, MD, Professor, Emory University: Hypoglycemia
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Exenatide; Insulin, Short-Acting

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Exenatide Inpatient	Exenatide Plus Glargine Insulin Inpatient	Basal Bolus Regimen Inpatient	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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: 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.	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: 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.	Patients are treated with insulin only
Period Title: Inpatient
STARTED	47	51	52	0	0
COMPLETED	43	50	52	0	0
NOT COMPLETED	4	1	0	0	0
Period Title: Inpatient
STARTED	0	0	0	48	55
COMPLETED	0	0	0	42	43
NOT COMPLETED	0	0	0	6	12

Baseline Characteristics

Arm/Group Title	Exenatide Inpatient	Exenatide Plus Glargine Insulin Inpatient	Basal Bolus Regimen Inpatient	Exenatide Outpatient	Insulin Only Outpatient	Total
Arm/Group Description	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: 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.	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: 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.	patients will be treated with Insulin only	Total of all reporting groups
Overall Participants	47	51	52	48	55	253
Age (years) [Mean (Standard Deviation) ]
Inpatient	55 (12)	55 (12)	57 (11)	56 (12)
Outpatient	52.7 (12.9)	54.8 (10.0)	53.1 (11.1)
Sex: Female, Male (Count of Participants)
Female	23 48.9%	25 49%	26 50%	0 0%	0 0%	74 29.2%
Male	24 51.1%	26 51%	26 50%	0 0%	0 0%	76 30%
Female	0 0%	0 0%	0 0%	21 43.8%	27 49.1%	48 19%
Male	0 0%	0 0%	0 0%	27 56.3%	28 50.9%	55 21.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	35 74.5%	33 64.7%	35 67.3%	0 0%	0 0%	103 40.7%
White	10 21.3%	15 29.4%	16 30.8%	0 0%	0 0%	41 16.2%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	2 4.3%	3 5.9%	1 1.9%	0 0%	0 0%	6 2.4%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	38 79.2%	43 78.2%	81 32%
White	0 0%	0 0%	0 0%	8 16.7%	12 21.8%	20 7.9%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	2 4.2%	0 0%	2 0.8%
Region of Enrollment (Count of Participants)
Inpatient	47 100%	51 100%	52 100%	0 0%	0 0%	150 59.3%
Outpatient	0 0%	0 0%	0 0%	48 100%	55 100%	103 40.7%

Outcome Measures

1. Primary Outcome

Title	Mean Daily Blood Glucose Concentration Inpatient
Description	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).
Time Frame	Duration of hospital stay, an expected average of 10 days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Mean (Standard Deviation) [mg/dL]	177.1 (41)	154.1 (39)	166.1 (40)

2. Primary Outcome

Title	Change in HbA1c Concentration Inpatient
Description	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.
Time Frame	12 weeks from discharge.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Mean (Standard Deviation) [percentage of HbA1c]	-1.3 (1.5)	-1.1 (2.2)	-1.4 (1.1)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Mean (Standard Deviation) [mg/dL]	177.1 (46.8)	146.8 (39.7)	157.7 (47.0)

4. Secondary Outcome

Title	Mean Premeal Blood Glucose Levels Inpatient
Description	The blood glucose levels prior to each meal will using a glucose meter.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Mean (Standard Deviation) [mg/dL]	178.7 (42.8)	153.4 (39.4)	161.8 (42.1)

5. Secondary Outcome

Title	Incidence of Hypoglycemic Events Inpatient
Description	The number of patients with hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Count of Participants [Participants]	0 0%	3 5.9%	6 11.5%

6. Secondary Outcome

Title	Incidence of Hyperglycemic Events Inpatient
Description	Percent of readings with hyperglycemia (blood glucose levels > 240 mg/dL)
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Mean (Standard Deviation) [percentage of readings]	10.4 (24)	5.1 (16)	11.2 (23)

7. Secondary Outcome

Title	Total Daily Dose of Insulin Inpatient
Description	The total daily dose of insulin needed for glycemic control from baseline through the patient's hospital stay will be recorded.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Mean (Standard Deviation) [units/day]	8.1 (5)	17.7 (11)	28 (15)

8. Secondary Outcome

Title	Average Number of Days of Hospital Stay
Description	The average number of days in the hospital for subjects will be calculated.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Median (Inter-Quartile Range) [days]	4	5	4

9. Secondary Outcome

Title	Incidence of the Need for ICU Care Inpatient
Description	The total number of patients who require transfer to the ICU will be recorded.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Count of Participants [Participants]	2 4.3%	3 5.9%	0 0%

10. Secondary Outcome

Title	Hospital Mortality
Description	The total number of subject deaths during hospital stay will be recorded.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Count of Participants [Participants]	0 0%	0 0%	0 0%

11. Secondary Outcome

Title	Hospital Complications
Description	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.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Count of Participants [Participants]	4 8.5%	6 11.8%	3 5.8%

12. Secondary Outcome

Title	Incidence of Acute Kidney Injury Inpatient
Description	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.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Count of Participants [Participants]	3 6.4%	6 11.8%	3 5.8%

13. Secondary Outcome

Title	Incidence of Gastrointestinal Adverse Events Inpatient
Description	The number of subjects who experience gastrointestinal side effects including nausea, vomiting and diarrhea will be recorded.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Count of Participants [Participants]	5 10.6%	5 9.8%	1 1.9%

14. Secondary Outcome

Title	Number of Patients With Severe Hypoglycemic Events Inpatient
Description	Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be recorded.
Time Frame	Duration of hospital stay, an expected average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Count of Participants [Participants]	0 0%	0 0%	0 0%

15. Secondary Outcome

Title	Incidence of Hospital Readmissions
Description	The number of patients who require readmission to the hospital from the time of discharge to 12 weeks after discharge will be recorded.
Time Frame	12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide	Exenatide Plus Glargine Insulin	Basal Bolus Regimen
Arm/Group Description	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: 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.	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.
Measure Participants	46	50	52
Count of Participants [Participants]	4 8.5%	16 31.4%	6 11.5%

16. Secondary Outcome

Title	Mean Fasting Blood Glucose Levels During Outpatient Period
Description	Fasting Blood Glucose Levels were measured using blood test
Time Frame	12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Mean (Standard Deviation) [mg/dL]	146.5 (62.7)	133.2 (26.1)

17. Secondary Outcome

Title	Mean Daily Blood Glucose Concentration During Outpatient Period
Description	Mean Daily Blood Glucose Concentration will be calculated and recorded.
Time Frame	12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Mean (Standard Deviation) [mg/dL]	155.1 (60.9)	144.7 (31.6)

18. Secondary Outcome

Title	The Number of Patients With Hypoglycemia Outpatient
Description	Occurrence of hypoglycemia (blood glucose levels < 70 mg) will be identified by blood test
Time Frame	12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Count of Participants [Participants]	7 14.9%	7 13.7%

19. Secondary Outcome

Title	Number of Patients With Severe Hypoglycemic Events
Description	Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be detected by blood test
Time Frame	12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Count of Participants [Participants]	1 2.1%	4 7.8%

20. Secondary Outcome

Title	Change in Body Weight
Description	The change in Body Weight from discharge to 12 weeks after discharge will be recorded
Time Frame	Time of discharge, 12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Mean (Standard Deviation) [pounds]	-2.3 (7.0)	-1.2 (9.3)

21. Secondary Outcome

Title	Change in Body Mass Index
Description	The change in BMI from discharge to 12 weeks after discharge will be calculated
Time Frame	Discharge (after day 10 or hospital stay), 12 weeks after discharge 12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Mean (Standard Deviation) [kg/m2]	-0.8 (2.6)	-0.7 (2.6)

22. Secondary Outcome

Title	Number of Patients Who Had Emergency Room Visits
Description	The number of patients who had emergency room visits from the time of discharge to 12 weeks after discharge will be recorded.
Time Frame	12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Number [participants]	4 8.5%	12 23.5%

23. Secondary Outcome

Title	Number of Hospital Readmissions
Description	Number of hospital readmissions during 12 weeks after discharge will be recorded
Time Frame	12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Number [number of readmissions]	12	14

24. Secondary Outcome

Title	Number of Acute Kidney Injury Events
Description	Number of Acute Kidney Injury events will be recorded
Time Frame	12 weeks from discharge.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Number [number of events]	1	1

25. Secondary Outcome

Title	Number of Severe Gastrointestinal Adverse Events
Description	Number of Severe (require hospitalization) Gastrointestinal Adverse Events
Time Frame	12 weeks from discharge.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Number [number of events]	1	1

26. Secondary Outcome

Title	Change in Systolic Blood Pressure
Description	Change in Systolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded
Time Frame	Discharge (after day 10 or hospital stay), 12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Mean (Standard Deviation) [mmHg]	3.2 (24.3)	1.8 (16.4)

27. Secondary Outcome

Title	Change in Heart Rate
Description	Change in heart rate from the time of discharge to 12 weeks after discharge will be recorded
Time Frame	Discharge (after day 10 or hospital stay), 12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Mean (Standard Deviation) [heart beats/min]	-3.1 (9.8)	0.2 (12.9)

28. Secondary Outcome

Title	Efficacy, Measured by HbA1c Levels and no Weight Gain
Description	Number of patients who have an HbA1c <7.0% and no weight gain at 12 weeks from discharge will be recorded.
Time Frame	12 weeks from discharge.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Count of Participants [Participants]	8 17%	5 9.8%

29. Secondary Outcome

Title	Efficacy, Measured by HbA1c Levels and no Hypoglycemia
Description	Number of patients who have an HbA1c <7.0% and no hypoglycemia at 12 weeks from discharge will be recorded.
Time Frame	12 weeks from discharge.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Count of Participants [Participants]	11 23.4%	8 15.7%

30. Secondary Outcome

Title	Change in Diastolic Blood Pressure
Description	Change in Diastolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded
Time Frame	Discharge (after day 10 or hospital stay), 12 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exenatide Outpatient	Insulin Only Outpatient
Arm/Group Description	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.	Patients are treated with insulin only
Measure Participants	42	43
Mean (Standard Deviation) [mmHg]	4.2 (15.6)	-1.0 (11.7)

Adverse Events

Time Frame	14 weeks (up to 2 weeks inpatient and 12 weeks outpatient)
Arm/Group Title	Exenatide Inpatient		Exenatide Plus Glargine Insulin Inpatient		Basal Bolus Regimen Inpatient		Exenatide Outpatient		Insulin Only Outpatient
Arm/Group Description	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: 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.		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: 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.		Patients with Type 2 Diabetes treated with Insulin only
All Cause Mortality
	Exenatide Inpatient		Exenatide Plus Glargine Insulin Inpatient		Basal Bolus Regimen Inpatient		Exenatide Outpatient		Insulin Only Outpatient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/51 (0%)		0/52 (0%)		1/48 (2.1%)		0/55 (0%)
Serious Adverse Events
	Exenatide Inpatient		Exenatide Plus Glargine Insulin Inpatient		Basal Bolus Regimen Inpatient		Exenatide Outpatient		Insulin Only Outpatient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/47 (14.9%)		12/51 (23.5%)		8/52 (15.4%)		11/48 (22.9%)		11/55 (20%)
Cardiac disorders
Heart failure	0/47 (0%)	0	0/51 (0%)	0	1/52 (1.9%)	1	2/48 (4.2%)	2	2/55 (3.6%)	2
Cardiac Arrhythmia	0/47 (0%)		0/51 (0%)		0/52 (0%)		0/48 (0%)		1/55 (1.8%)	1
Gastrointestinal disorders
Gastro-intestinal event	0/47 (0%)		0/51 (0%)		0/52 (0%)		1/48 (2.1%)	1	1/55 (1.8%)	1
General disorders
Composite complications	3/47 (6.4%)	3	6/51 (11.8%)	6	4/52 (7.7%)	4	4/48 (8.3%)	4	2/55 (3.6%)	2
Infections and infestations
Infection	0/47 (0%)		0/51 (0%)		0/52 (0%)		2/48 (4.2%)	2	2/55 (3.6%)	2
Renal and urinary disorders
Acute renal failure	3/47 (6.4%)	3	6/51 (11.8%)	6	3/52 (5.8%)	3	0/48 (0%)	3	0/55 (0%)	3
Acute Kidney Injury	0/47 (0%)		0/51 (0%)		0/52 (0%)		1/48 (2.1%)	1	1/55 (1.8%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/47 (2.1%)	1	0/51 (0%)	0	0/52 (0%)	0	0/48 (0%)	0	0/55 (0%)	0
Surgical and medical procedures
Surgery	0/47 (0%)		0/51 (0%)		0/52 (0%)		1/48 (2.1%)	1	0/55 (0%)	1
Vascular disorders
Stroke	0/47 (0%)		0/51 (0%)		0/52 (0%)		0/48 (0%)		1/55 (1.8%)	1
Acute Coronary syndrome	0/47 (0%)		0/51 (0%)		0/52 (0%)		0/48 (0%)		1/55 (1.8%)	1
Other (Not Including Serious) Adverse Events
	Exenatide Inpatient		Exenatide Plus Glargine Insulin Inpatient		Basal Bolus Regimen Inpatient		Exenatide Outpatient		Insulin Only Outpatient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/47 (10.6%)		5/51 (9.8%)		1/52 (1.9%)		20/48 (41.7%)		1/55 (1.8%)
Gastrointestinal disorders
Vomiting	1/47 (2.1%)	1	3/51 (5.9%)	3	0/52 (0%)	0	11/48 (22.9%)	11	1/55 (1.8%)	1
Nausea	5/47 (10.6%)	5	5/51 (9.8%)	5	1/52 (1.9%)	1	20/48 (41.7%)	20	1/55 (1.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.