Type 2 Diabetes
Conditions
Keywords
Hypoglycemia
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.
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.
Interventions
DRUGExenatide
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.
DRUGGlargine
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. 1. FBG \>180 mg/dL, no hypoglycemia; glargine increased by 4 IU. 2. FBG \>140 mg/dL, no hypoglycemia; glargine increased by 2 IU. 3. FBG 100-140 mg/dL, no hypoglycemia; no change in dosage. 4. FBG 70 - 99 mg/dl, decrease glargine by 4 IU or 10% of TDD. 5. FBG or RBG \< 70 mg/dl, decrease glargine by 8 IU or 20% of TDD. 6. FBG or RBG \< 40 mg/dl, decrease dose of glargine by 30%.
DRUGRapid-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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hospital Mortality | Duration of hospital stay, an expected average of 10 days | The total number of subject deaths during hospital stay will be recorded. |
| 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. |
| 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. |
| 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) |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Mean Fasting Blood Glucose Levels During Outpatient Period | 12 weeks after discharge | Fasting Blood Glucose Levels were measured using blood test |
| Mean Daily Blood Glucose Concentration During Outpatient Period | 12 weeks after discharge | Mean Daily Blood Glucose Concentration will be calculated and recorded. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
| Number of Hospital Readmissions | 12 weeks after discharge | Number of hospital readmissions during 12 weeks after discharge will be recorded |
| Number of Acute Kidney Injury Events | 12 weeks from discharge. | Number of Acute Kidney Injury events will be recorded |
| Number of Severe Gastrointestinal Adverse Events | 12 weeks from discharge. | Number of Severe (require hospitalization) Gastrointestinal Adverse Events |
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| 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. | 51 |
| 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. | 52 |
| 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. | 48 |
| Insulin Only Outpatient patients will be treated with Insulin only | 55 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Inpatient | Adverse Event | 3 | 0 | 0 | 0 | 0 |
| Inpatient | Discharged <24 h after admission | 0 | 1 | 0 | 0 | 0 |
| Inpatient | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
| Outpatient | Adverse Event | 0 | 0 | 0 | 5 | 0 |
| Outpatient | Lost to Follow-up | 0 | 0 | 0 | 1 | 12 |
Baseline characteristics
| Characteristic | Exenatide Inpatient | Exenatide Plus Glargine Insulin Inpatient | Basal Bolus Regimen Inpatient | Total | Exenatide Outpatient | Insulin Only Outpatient |
|---|---|---|---|---|---|---|
| Age, Continuous Inpatient | 55 years STANDARD_DEVIATION 12 | 55 years STANDARD_DEVIATION 12 | 57 years STANDARD_DEVIATION 11 | 56 years STANDARD_DEVIATION 12 | — | — |
| Age, Continuous Outpatient | — | — | — | 53.1 years STANDARD_DEVIATION 11.1 | 52.7 years STANDARD_DEVIATION 12.9 | 54.8 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) Inpatient American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Inpatient Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Inpatient Black or African American | 35 Participants | 33 Participants | 35 Participants | 103 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Inpatient More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Inpatient Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Inpatient Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants | 6 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Inpatient White | 10 Participants | 15 Participants | 16 Participants | 41 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Outpatient American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Outpatient Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Outpatient Black or African American | 0 Participants | 0 Participants | 0 Participants | 81 Participants | 38 Participants | 43 Participants |
| Race (NIH/OMB) Outpatient More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Outpatient Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Outpatient Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Outpatient White | 0 Participants | 0 Participants | 0 Participants | 20 Participants | 8 Participants | 12 Participants |
| Region of Enrollment United States Inpatient | 47 Participants | 51 Participants | 52 Participants | 150 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States Outpatient | 0 Participants | 0 Participants | 0 Participants | 103 Participants | 48 Participants | 55 Participants |
| Sex: Female, Male Inpatient Female | 23 Participants | 25 Participants | 26 Participants | 74 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Inpatient Male | 24 Participants | 26 Participants | 26 Participants | 76 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Outpatient Female | 0 Participants | 0 Participants | 0 Participants | 48 Participants | 21 Participants | 27 Participants |
| Sex: Female, Male Outpatient Male | 0 Participants | 0 Participants | 0 Participants | 55 Participants | 27 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 51 | 0 / 52 | 1 / 48 | 0 / 55 |
| other Total, other adverse events | 5 / 47 | 5 / 51 | 1 / 52 | 20 / 48 | 1 / 55 |
| serious Total, serious adverse events | 7 / 47 | 12 / 51 | 8 / 52 | 11 / 48 | 11 / 55 |
Outcome results
Primary
Change in HbA1c Concentration Inpatient
The difference in the levels of HbA1c at discharge and at 12 weeks from discharge will be measured. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.
Time frame: 12 weeks from discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in HbA1c Concentration Inpatient | -1.3 percentage of HbA1c | Standard Deviation 1.5 |
| Exenatide Plus Glargine Insulin | Change in HbA1c Concentration Inpatient | -1.1 percentage of HbA1c | Standard Deviation 2.2 |
| Basal Bolus Regimen | Change in HbA1c Concentration Inpatient | -1.4 percentage of HbA1c | Standard Deviation 1.1 |
Primary
Mean Daily Blood Glucose Concentration Inpatient
The levels of blood glucose (BG) will be measured before each meal and at bedtime using a glucose meter. Blood glucose will be measured at baseline and during the hospital stay (up to 10 days).
Time frame: Duration of hospital stay, an expected average of 10 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Mean Daily Blood Glucose Concentration Inpatient | 177.1 mg/dL | Standard Deviation 41 |
| Exenatide Plus Glargine Insulin | Mean Daily Blood Glucose Concentration Inpatient | 154.1 mg/dL | Standard Deviation 39 |
| Basal Bolus Regimen | Mean Daily Blood Glucose Concentration Inpatient | 166.1 mg/dL | Standard Deviation 40 |
Secondary
Average Number of Days of Hospital Stay
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exenatide | Average Number of Days of Hospital Stay | 4 days |
| Exenatide Plus Glargine Insulin | Average Number of Days of Hospital Stay | 5 days |
| Basal Bolus Regimen | Average Number of Days of Hospital Stay | 4 days |
Secondary
Change in Body Mass Index
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Body Mass Index | -0.8 kg/m2 | Standard Deviation 2.6 |
| Exenatide Plus Glargine Insulin | Change in Body Mass Index | -0.7 kg/m2 | Standard Deviation 2.6 |
Secondary
Change in Body Weight
The change in Body Weight from discharge to 12 weeks after discharge will be recorded
Time frame: Time of discharge, 12 weeks after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Body Weight | -2.3 pounds | Standard Deviation 7 |
| Exenatide Plus Glargine Insulin | Change in Body Weight | -1.2 pounds | Standard Deviation 9.3 |
Secondary
Change in Diastolic Blood Pressure
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Diastolic Blood Pressure | 4.2 mmHg | Standard Deviation 15.6 |
| Exenatide Plus Glargine Insulin | Change in Diastolic Blood Pressure | -1.0 mmHg | Standard Deviation 11.7 |
Secondary
Change in Heart Rate
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Heart Rate | -3.1 heart beats/min | Standard Deviation 9.8 |
| Exenatide Plus Glargine Insulin | Change in Heart Rate | 0.2 heart beats/min | Standard Deviation 12.9 |
Secondary
Change in Systolic Blood Pressure
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Systolic Blood Pressure | 3.2 mmHg | Standard Deviation 24.3 |
| Exenatide Plus Glargine Insulin | Change in Systolic Blood Pressure | 1.8 mmHg | Standard Deviation 16.4 |
Secondary
Efficacy, Measured by HbA1c Levels and no Hypoglycemia
Number of patients who have an HbA1c \<7.0% and no hypoglycemia at 12 weeks from discharge will be recorded.
Time frame: 12 weeks from discharge.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Efficacy, Measured by HbA1c Levels and no Hypoglycemia | 11 Participants |
| Exenatide Plus Glargine Insulin | Efficacy, Measured by HbA1c Levels and no Hypoglycemia | 8 Participants |
Secondary
Efficacy, Measured by HbA1c Levels and no Weight Gain
Number of patients who have an HbA1c \<7.0% and no weight gain at 12 weeks from discharge will be recorded.
Time frame: 12 weeks from discharge.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Efficacy, Measured by HbA1c Levels and no Weight Gain | 8 Participants |
| Exenatide Plus Glargine Insulin | Efficacy, Measured by HbA1c Levels and no Weight Gain | 5 Participants |
Secondary
Hospital Complications
The total number of subjects who experience hospital complications like nosocomial pneumonia, bacteremia, respiratory failure, acute renal failure, and wound infections (surgery patients) will be recorded. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.
Time frame: Duration of hospital stay, an expected average of 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Hospital Complications | 4 Participants |
| Exenatide Plus Glargine Insulin | Hospital Complications | 6 Participants |
| Basal Bolus Regimen | Hospital Complications | 3 Participants |
Secondary
Hospital Mortality
The total number of subject deaths during hospital stay will be recorded.
Time frame: Duration of hospital stay, an expected average of 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Hospital Mortality | 0 Participants |
| Exenatide Plus Glargine Insulin | Hospital Mortality | 0 Participants |
| Basal Bolus Regimen | Hospital Mortality | 0 Participants |
Secondary
Incidence of Acute Kidney Injury Inpatient
The number of patients who experience acute kidney injury diagnosed by an increment in serum creatinine \>0.5 mg/dL from admission value or 50% of baseline value will be recorded.
Time frame: Duration of hospital stay, an expected average of 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Incidence of Acute Kidney Injury Inpatient | 3 Participants |
| Exenatide Plus Glargine Insulin | Incidence of Acute Kidney Injury Inpatient | 6 Participants |
| Basal Bolus Regimen | Incidence of Acute Kidney Injury Inpatient | 3 Participants |
Secondary
Incidence of Gastrointestinal Adverse Events Inpatient
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Incidence of Gastrointestinal Adverse Events Inpatient | 5 Participants |
| Exenatide Plus Glargine Insulin | Incidence of Gastrointestinal Adverse Events Inpatient | 5 Participants |
| Basal Bolus Regimen | Incidence of Gastrointestinal Adverse Events Inpatient | 1 Participants |
Secondary
Incidence of Hospital Readmissions
The number of patients who require readmission to the hospital from the time of discharge to 12 weeks after discharge will be recorded.
Time frame: 12 weeks after discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Incidence of Hospital Readmissions | 4 Participants |
| Exenatide Plus Glargine Insulin | Incidence of Hospital Readmissions | 16 Participants |
| Basal Bolus Regimen | Incidence of Hospital Readmissions | 6 Participants |
Secondary
Incidence of Hyperglycemic Events Inpatient
Percent of readings with hyperglycemia (blood glucose levels \> 240 mg/dL)
Time frame: Duration of hospital stay, an expected average of 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Incidence of Hyperglycemic Events Inpatient | 10.4 percentage of readings | Standard Deviation 24 |
| Exenatide Plus Glargine Insulin | Incidence of Hyperglycemic Events Inpatient | 5.1 percentage of readings | Standard Deviation 16 |
| Basal Bolus Regimen | Incidence of Hyperglycemic Events Inpatient | 11.2 percentage of readings | Standard Deviation 23 |
Secondary
Incidence of Hypoglycemic Events Inpatient
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Incidence of Hypoglycemic Events Inpatient | 0 Participants |
| Exenatide Plus Glargine Insulin | Incidence of Hypoglycemic Events Inpatient | 3 Participants |
| Basal Bolus Regimen | Incidence of Hypoglycemic Events Inpatient | 6 Participants |
Secondary
Incidence of the Need for ICU Care Inpatient
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Incidence of the Need for ICU Care Inpatient | 2 Participants |
| Exenatide Plus Glargine Insulin | Incidence of the Need for ICU Care Inpatient | 3 Participants |
| Basal Bolus Regimen | Incidence of the Need for ICU Care Inpatient | 0 Participants |
Secondary
Mean Daily Blood Glucose Concentration During Outpatient Period
Mean Daily Blood Glucose Concentration will be calculated and recorded.
Time frame: 12 weeks after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Mean Daily Blood Glucose Concentration During Outpatient Period | 155.1 mg/dL | Standard Deviation 60.9 |
| Exenatide Plus Glargine Insulin | Mean Daily Blood Glucose Concentration During Outpatient Period | 144.7 mg/dL | Standard Deviation 31.6 |
Secondary
Mean Fasting Blood Glucose Levels During Outpatient Period
Fasting Blood Glucose Levels were measured using blood test
Time frame: 12 weeks after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Mean Fasting Blood Glucose Levels During Outpatient Period | 146.5 mg/dL | Standard Deviation 62.7 |
| Exenatide Plus Glargine Insulin | Mean Fasting Blood Glucose Levels During Outpatient Period | 133.2 mg/dL | Standard Deviation 26.1 |
Secondary
Mean Fasting Blood Glucose Levels Inpatient
The blood glucose levels prior to the patient's first meal of the day will be assessed using a glucose meter.
Time frame: Duration of hospital stay, an expected average of 10 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Mean Fasting Blood Glucose Levels Inpatient | 177.1 mg/dL | Standard Deviation 46.8 |
| Exenatide Plus Glargine Insulin | Mean Fasting Blood Glucose Levels Inpatient | 146.8 mg/dL | Standard Deviation 39.7 |
| Basal Bolus Regimen | Mean Fasting Blood Glucose Levels Inpatient | 157.7 mg/dL | Standard Deviation 47 |
Secondary
Mean Premeal Blood Glucose Levels Inpatient
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Mean Premeal Blood Glucose Levels Inpatient | 178.7 mg/dL | Standard Deviation 42.8 |
| Exenatide Plus Glargine Insulin | Mean Premeal Blood Glucose Levels Inpatient | 153.4 mg/dL | Standard Deviation 39.4 |
| Basal Bolus Regimen | Mean Premeal Blood Glucose Levels Inpatient | 161.8 mg/dL | Standard Deviation 42.1 |
Secondary
Number of Acute Kidney Injury Events
Number of Acute Kidney Injury events will be recorded
Time frame: 12 weeks from discharge.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Number of Acute Kidney Injury Events | 1 number of events |
| Exenatide Plus Glargine Insulin | Number of Acute Kidney Injury Events | 1 number of events |
Secondary
Number of Hospital Readmissions
Number of hospital readmissions during 12 weeks after discharge will be recorded
Time frame: 12 weeks after discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Number of Hospital Readmissions | 12 number of readmissions |
| Exenatide Plus Glargine Insulin | Number of Hospital Readmissions | 14 number of readmissions |
Secondary
Number of Patients Who Had Emergency Room Visits
The number of patients who had emergency room visits from the time of discharge to 12 weeks after discharge will be recorded.
Time frame: 12 weeks after discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Number of Patients Who Had Emergency Room Visits | 4 participants |
| Exenatide Plus Glargine Insulin | Number of Patients Who Had Emergency Room Visits | 12 participants |
Secondary
Number of Patients With Severe Hypoglycemic Events
Occurrences of hypoglycemia (blood glucose levels \< 40 mg/dL) will be detected by blood test
Time frame: 12 weeks after discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Number of Patients With Severe Hypoglycemic Events | 1 Participants |
| Exenatide Plus Glargine Insulin | Number of Patients With Severe Hypoglycemic Events | 4 Participants |
Secondary
Number of Patients With Severe Hypoglycemic Events Inpatient
Occurrences of hypoglycemia (blood glucose levels \< 40 mg/dL) will be recorded.
Time frame: Duration of hospital stay, an expected average of 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | Number of Patients With Severe Hypoglycemic Events Inpatient | 0 Participants |
| Exenatide Plus Glargine Insulin | Number of Patients With Severe Hypoglycemic Events Inpatient | 0 Participants |
| Basal Bolus Regimen | Number of Patients With Severe Hypoglycemic Events Inpatient | 0 Participants |
Secondary
Number of Severe Gastrointestinal Adverse Events
Number of Severe (require hospitalization) Gastrointestinal Adverse Events
Time frame: 12 weeks from discharge.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Number of Severe Gastrointestinal Adverse Events | 1 number of events |
| Exenatide Plus Glargine Insulin | Number of Severe Gastrointestinal Adverse Events | 1 number of events |
Secondary
The Number of Patients With Hypoglycemia Outpatient
Occurrence of hypoglycemia (blood glucose levels \< 70 mg) will be identified by blood test
Time frame: 12 weeks after discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide | The Number of Patients With Hypoglycemia Outpatient | 7 Participants |
| Exenatide Plus Glargine Insulin | The Number of Patients With Hypoglycemia Outpatient | 7 Participants |
Secondary
Total Daily Dose of Insulin Inpatient
The total daily dose of insulin needed for glycemic control from baseline through the patient's hospital stay will be recorded.
Time frame: Duration of hospital stay, an expected average of 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Total Daily Dose of Insulin Inpatient | 8.1 units/day | Standard Deviation 5 |
| Exenatide Plus Glargine Insulin | Total Daily Dose of Insulin Inpatient | 17.7 units/day | Standard Deviation 11 |
| Basal Bolus Regimen | Total Daily Dose of Insulin Inpatient | 28 units/day | Standard Deviation 15 |