Randomized Clinical Trial of Subcutaneous Analog Basal Bolus Therapy Versus Sliding Scale Human Regular Insulin in the Hospital Management of Hyperglycemia in Non-Critically Ill Patients Without Known History of Diabetes: The HMH Trial
概览
- 阶段
- 3 期
- 干预措施
- Human regular insulin
- 疾病 / 适应症
- Hyperglycemia
- 发起方
- Eli Lilly and Company
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Mean Plasma Glucose (MPG) Throughout Hospital Study Period
- 状态
- 终止
- 最后更新
- 13年前
概览
简要总结
The purpose of this study is to compare the use of insulin glargine plus insulin lispro to human regular insulin for treatment of hyperglycemia in the hospital setting in patients without known prior history of diabetes.
详细描述
This study involves a comparison of 2 methods for administering subcutaneous insulin therapy to non-critically ill adult patients with hyperglycemia and without known history of diabetes who are admitted to non-intensive care unit (ICU) general medical hospital services. Basal-bolus therapy, considered the gold standard for glucose control in patients with known diabetes, will be compared with sliding scale insulin, a commonly used method of glucose control (prevailing standard practice) in hospitalized patients. In this study, basal-bolus therapy will consist of once-daily glargine plus lispro 3 to 4 times daily adjusted to achieve pre-meal capillary plasma glucose \<140 milligrams per deciliter (mg/dL) and bedtime capillary plasma glucose \<180 mg/dL for patients who are eating \[predose plasma glucose \<140 mg/dL for patients with nil per os (NPO) orders\]; sliding scale insulin will be administered using human regular insulin 4 times daily as needed adjusted to achieve predose capillary plasma glucose target \<140 mg/dL in patients who are eating or have NPO orders.
研究者
入排标准
入选标准
- •No known history of diabetes
- •Admission or pre-entry plasma glucose (PG) level between 140 and 400 mg/dL
- •Non-critically ill and admitted to acute care medical services
- •Have a body mass index greater than or equal to 18.5 kg/m\^2 and less than or equal to 45 kilograms per square meter (kg/m\^2)
排除标准
- •Received any insulin/analog therapy for longer than 108 hours prior to study entry or intermediate- or long-acting insulin/analogs (neutral protamine Hagedorn, detemir, or glargine) in the 24 hours prior to randomization or any intravenous insulin therapy prior to randomization
- •Laboratory evidence of diabetic ketoacidosis for patients with pre-randomization PG greater than 250 mg/dL
- •Have taken any oral or injectable antihyperglycemic medications other than insulin within 3 months prior to study entry
- •Have acute critical illness or are expected to require admission to an ICU or equivalent or be treated with glucocorticoid therapy during the hospital study period
- •Expected hospitalization less than 24 hours post-randomization
研究组 & 干预措施
Sliding scale regular insulin
干预措施: Human regular insulin
Basal-bolus therapy
干预措施: Insulin lispro
Basal-bolus therapy
干预措施: Insulin glargine
结局指标
主要结局
Mean Plasma Glucose (MPG) Throughout Hospital Study Period
时间窗: Throughout hospital study period (1 to 10 days post-randomization)
Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10.
Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period
时间窗: Throughout hospital study period (1 to 10 days post-randomization)
Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm.
次要结局
- Mean Plasma Glucose (MPG) by Hospital Day(Day 1 up to day 7 of hospital study period)
- Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day(Day 1 up to day 10 of hospital study period)
- Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL Throughout Hospital Study Period(Throughout hospital study period (1 to 10 days post-randomization))
- Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL by Hospital Day(Day 1 up to day 10 of hospital study period)
- Mean Fasting Plasma Glucose (FPG) by Hospital Day(Day 1 up to day 10 of hospital study period)
- Mean FPG Throughout Hospital Study Period(Throughout hospital study period (1 to 10 days post-randomization))
- Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period(Throughout the hospital study period (1 to 10 days post-randomization))
- Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day(Day 1 up to day 10 of hospital study period)
- Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL Throughout the Hospital Study Period(Throughout the hospital study period (1 to 10 days post-randomization))
- Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day(Day 1 up to day 10 of hospital study period)
- Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period(Throughout the hospital study period (1 to 10 days post-randomization))
- Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day(Day 1 up to day 10 of hospital study period)
- Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period(Throughout the hospital study period (1 to 10 days post-randomization))
- TDD of Insulin (Units/kg) Throughout the Hospital Study Period(Throughout the hospital study period (1 to 10 days post-randomization))
- TDD of Insulin (Units) by Hospital Day(Day 1 up to day 10 of hospital study period)
- TDD of Insulin (Units/kg) by Hospital Day(Day 1 up to day 10 of hospital study period)
- Length of Hospital Stay Post-randomization Throughout the Hospital Study Period(Throughout the hospital study period (1 to 10 days post-randomization))
- Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period(Throughout hospital study period (1 to 10 days post-randomization))
- Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period(Throughout hospital study period (1 to 10 days post-randomization))
- Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day(Day 1 up to day 10 of hospital study period)
- Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day(Day 1 up to day 10 of hospital study period)
- Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period(Throughout hospital study period (1 to 10 days post-randomization))
- Percentage of Participants Requiring Intensive Care Unit Transfer(Throughout hospital study period (1 to 10 days post-randomization))
- Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period(Throughout hospital study period (1 to 10 days post-randomization))
- Percentage of Participants With Documented Nosocomial Infections(Throughout hospital study period (1 to 10 days post-randomization))
- Number of Participants With Major Adverse Cardiovascular Events (MACE)(Throughout hospital study period (1 to 10 days post-randomization))