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
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT02455076
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- A known history of Type 2 Diabetes receiving either diet alone or oral antidiabetic drugs (OAD) including insulin secretagogues, pioglitazone, DPP4 inhibitors, or metformin as monotherapy or in combination therapy, or low-dose insulin at <0.5 unit/kg/day.
- Males or females between the ages of 18 and 80 years discharged after hospital admission from general medicine and surgery services (non-Intensive Care Unit setting).
- Subjects with an admission / randomization BG < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
- Admission HbA1c between 7% and 10%
- BMI range: > 25 Kg/m^2 and < 45 Kg/m^2
- Age < 18 or > 80 years
- Subjects with increased blood glucose (BG) concentration, but without a history of diabetes (stress hyperglycemia)
- Subjects with a history of type 1 diabetes (suggested by BMI < 25 Kg/m^2 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria).
- Treatment with high-dose (>0.5 unit/kg/day) insulin or with GLP-1 RA during the past 3 months prior to admission.
- Patients that required ICU care during the hospital admission.
- Recurrent severe hypoglycemia or hypoglycemic unawareness.
- Subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or those expected to require gastrointestinal suction.
- Patients with clinically relevant pancreatic or gallbladder disease.
- Patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
- Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease),
- History of hypersensitivity to exenatide
- Treatment with oral or injectable corticosteroid (equal to a prednisone dose >5 mg/day), parenteral nutrition and immunosuppressive treatment.
- Patients with history of heavy alcohol use (female > 2 drinks per day, male > 3 drinks per day) or drug abuse within 3 months prior to admission.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Female subjects who are pregnant or breast feeding at time of enrollment into the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exenatide plus glargine insulin inpatient Glargine 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. Basal bolus regimen inpatient Glargine 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. Basal bolus regimen inpatient Rapid-acting insulin analogs 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. Insulin Only Glargine Patients with Type 2 Diabetes will be treated with Insulin only Insulin Only Rapid-acting insulin analogs Patients with Type 2 Diabetes will be treated with Insulin only Exenatide inpatient Exenatide 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. Exenatide plus glargine insulin inpatient Exenatide 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. Exenatide outpatient Exenatide 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Hospital Mortality Duration of hospital stay, an expected average of 10 days The total number of subject deaths during hospital stay will be recorded.
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.
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.
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
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
Trial Locations
- Locations (2)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States