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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mean Daily Blood Glucose Concentration Inpatient
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Exenatide (Drug)
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.
干预措施: Exenatide (Drug)
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.
干预措施: Glargine (Drug)
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.
干预措施: Glargine (Drug)
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.
干预措施: Rapid-acting insulin analogs (Drug)
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.
干预措施: Exenatide (Drug)
Insulin Only
Patients with Type 2 Diabetes will be treated with Insulin only
干预措施: Glargine (Drug)
Insulin Only
Patients with Type 2 Diabetes will be treated with Insulin only
干预措施: Rapid-acting insulin analogs (Drug)
结局指标
主要结局
Mean Daily Blood Glucose Concentration Inpatient
时间窗: 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
时间窗: 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.
次要结局
- Average Number of Days of Hospital Stay(Duration of hospital stay, an expected average of 10 days)
- Incidence of the Need for ICU Care Inpatient(Duration of hospital stay, an expected average of 10 days)
- Hospital Mortality(Duration of hospital stay, an expected average of 10 days)
- Hospital Complications(Duration of hospital stay, an expected average of 10 days)
- Incidence of Acute Kidney Injury Inpatient(Duration of hospital stay, an expected average of 10 days)
- Incidence of Gastrointestinal Adverse Events Inpatient(Duration of hospital stay, an expected average of 10 days)
- Number of Patients With Severe Hypoglycemic Events Inpatient(Duration of hospital stay, an expected average of 10 days)
- Incidence of Hospital Readmissions(12 weeks after discharge)
- Mean Fasting Blood Glucose Levels During Outpatient Period(12 weeks after discharge)
- Mean Daily Blood Glucose Concentration During Outpatient Period(12 weeks after discharge)
- Mean Fasting Blood Glucose Levels Inpatient(Duration of hospital stay, an expected average of 10 days.)
- Mean Premeal Blood Glucose Levels Inpatient(Duration of hospital stay, an expected average of 10 days)
- Incidence of Hypoglycemic Events Inpatient(Duration of hospital stay, an expected average of 10 days)
- Incidence of Hyperglycemic Events Inpatient(Duration of hospital stay, an expected average of 10 days)
- Total Daily Dose of Insulin Inpatient(Duration of hospital stay, an expected average of 10 days)
- The Number of Patients With Hypoglycemia Outpatient(12 weeks after discharge)
- Number of Patients With Severe Hypoglycemic Events(12 weeks after discharge)
- Change in Body Weight(Time of discharge, 12 weeks after discharge)
- Change in Body Mass Index(Discharge (after day 10 or hospital stay), 12 weeks after discharge 12 weeks after discharge)
- Number of Patients Who Had Emergency Room Visits(12 weeks after discharge)
- Number of Hospital Readmissions(12 weeks after discharge)
- Number of Acute Kidney Injury Events(12 weeks from discharge.)
- Number of Severe Gastrointestinal Adverse Events(12 weeks from discharge.)
- Change in Systolic Blood Pressure(Discharge (after day 10 or hospital stay), 12 weeks after discharge)
- Change in Heart Rate(Discharge (after day 10 or hospital stay), 12 weeks after discharge)
- Efficacy, Measured by HbA1c Levels and no Weight Gain(12 weeks from discharge.)
- Efficacy, Measured by HbA1c Levels and no Hypoglycemia(12 weeks from discharge.)
- Change in Diastolic Blood Pressure(Discharge (after day 10 or hospital stay), 12 weeks after discharge)
研究者
Guillermo Umpierrez, MD
Professor
Emory University